Apparatus and method for use in investigating or assessing eye or pupil movement

Abstract

Apparatus (10) and method for personal application and use in capturing both eyes or pupil data / movement at onset or during an episode of dizziness / vertigo. Apparatus has eye / pupil motion imaging means (38), eye / pupil motion recording means (40), and at least one activation means e.g. an input device (14), configured for a patient to self-initiate operation of the apparatus, e.g. by a single operation of the input device, to commence the apparatus recording their eye or pupil movement during an episode of dizziness or vertigo. Apparatus is configured to complete recording the session and send the recorded data to a remote location or cloud storage for subsequent review without requiring the patient's functional input to the apparatus beyond the patient's self-activation of the apparatus.

Description

APPARATUS AND METHOD FOR USE IN INVESTIGATING OR ASSESSING EYE OR PUPIL MOVEMENT TECHNICAL FIELD

[0001] The present invention relates to the application of devices, apparatus, systems and methods to the investigation or assessment of changes in the eye, such as pupil position, pupil size, eye position and / or eye movement. Such investigation can include measuring, monitoring and / or recording eye / pupil movement.

[0002] One or more forms of the present invention relate(s) particularly, though not exclusively, applies to apparatus, system and / or method, or use thereof, for the investigation of motion and / or changes in the eye and pupil, such as eye position, pupil size, pupil position and / or eye movement (such eye motion patterns as in nystagmus), which may be associated with vestibular and other neurological disorders.BACKGROUND

[0003] The presence of a number of medical and health problems can be detected by changes in the eye and / or its pupil, including changes in the position, movement and dilation of the eye and / or its pupil. For example, it has been found that one of the leading causes of dizziness and balance problems is associated with the vestibular system in the inner ear or in the vestibular pathways and control centre of central nervous system.

[0004] Nystagmus refers to rapid involuntary eye movements presenting as one or both eyes moving from side to side, up and down or rotating or with discordance between the two eyes. Nystagmus is understood to be caused by neurological or inner ear disorders.

[0005] The presence of nystagmus during a dizziness attack can suggest to a clinician that there is a vertiginous component to it and the direction of the nystagmus may provide some evidence to a specialist in the field, of more specific information, such as which ear (or which part of the ear) has the active disease. In addition, the pattern of the nystagmus of one or both eyes can also indicate which part of the central nervous system is affected.

[0006] Dizziness and balance problems constitute a major public health problem. A significant proportion of adults have had an episode of dizziness occurring with enough intensity or frequency to promote a visit to the doctor. It is one of the most difficult complaints to assess, as it is a subjective symptom of potentially numerous causes. Dizziness is often an episodic symptom, with the frequency of episodes highly variable. As a patient will very rarely have an episode in the clinic, clinicians frequently need to rely solely on the patient's (often unintentionally misleading) report of the symptom.

[0007] Accordingly, accurate assessment / diagnosis of balance symptoms is important not only to exclude potentially serious central causes but also to aid successful treatment. Unfortunately, accurate assessment / diagnosis is not possible in most cases, or delayed.

[0008] Part of the difficulty is that incumbent nystagmography apparatus for detecting and recording nystagmus are large, expensive machines that are only available for use in-clinic by specialists. Due to the size, complexity and expense of these machines they are limited to laboratory or office-based use for specific tests. Those machines are not suited for use monitoring patients engaged in their everyday activities at the time of a dizzy attack.

[0009] Unfortunately, dizziness is a non-specific symptom and is often very difficult to assess. It is usually an episodic symptom with a high proportion of people reporting recurrent attacks. Episodes can last from seconds to days, and they frequently occur at home or work where there is often no means to record the symptoms of the event. As a result, the clinician often relies on the patient's account of their history of dizziness, and these accounts can be highly subjective and inconsistent.

[0010] A single nystagmus is rarely a useful clinical sign, rather a series of similar nystagmus must be observed. For this reason, velocities of all slow waves, measured and plotted over time, can give a useful clinical picture. Patients with nystagmus should preferably be observed for a period of 2 minutes or more to exclude the possibility of alternating nystagmus and to ensure that the current nystagmus are recorded accurately / clearly. Several recordings during one episode can track the progress of the symptoms. Several recordings can be used to detect recovery nystagmus (change of direction of nystagmus).

[0011] Where nystagmus can be recorded and movements tracked, clinicians are provided with an objective indicator of the underlying pathology and ultimately the cause of a patient's dizziness, vertigo or imbalance; this reduces reliance on artificially induced assessment, subjective interpretation and recall of symptoms by the patient, which is often misleading and an inefficient use of time and resources.

[0012] Known ‘in-clinic’ apparatus measure eye movements using Videonystagmography (VNG) equipment. These systems are large, expensive and limited to in-clinic use. They are primarily used to record eye movements during tests that are designed to bring on symptoms.

[0013] Apparatus and process for investigating nystagmus is discussed in international patent application PCT / AU2005 / 001671 published as W02006 / 047816.

[0014] International patent application PCT / AU2021 / 050398 (the contents of which are incorporated herein in their entirety by reference) by the present Applicant and published as WO2021 / 217218 also discusses assessing nystagmus.

[0015] However, such an apparatus and method have at least one underlying limitation and / or drawback. Particularly, it is extremely difficult, if not impossible, for a patient to use a previously proposed device themself away from the clinic due to the complexity of the user interface and / or useability, particularly during the onset of a debilitating episode of dizziness. An episode of dizziness can be so nauseous and debilitating for the patient / user that they cannot function or concentrate sufficiently to operate multiple buttons, select functions or establish a data connection. Reducing the complexity of use beneficially enables improved likelihood of good quality recordings from sessions to ensure improved outcomes for patients.

[0016] It is with the aforementioned in mind that the present invention has been developed. One or more forms of the present invention has been developed with a view to improving patient experience and usability with eye movement recording apparatus leading to improved and / or more reliable data capture for analysis in the investigation of changes in the eye(s) and / or pupil(s), such as for investigating the presence of nystagmus, episodes of dizziness or other eye feature (eye and / or pupil) movement related conditions.

[0017] References to prior art in this specification are provided for illustrative purposes only and are not to be taken as an admission that such prior art is part of the common general knowledge in Australia or elsewhere.SUMMARY

[0018] One or more embodiments of the present invention can be selfapplied or initiated by a person suffering an episode of dizziness used away from the clinic (e.g. temporarily for recording / sensing an episode or for a longer time period e.g. if a series of episodes occur close together) without need of operation by a specialist clinician or health care professional.

[0019] However, it will be understood that one or more embodiments may also be used more generally in oculography, particularly video-oculography (VOG) for measuring horizontal, vertical and torsional position components of the movements of both eyes (eye tracking).

[0020] One or more embodiments may be employed for the investigation of feature and / or changes of one or more eye features e.g. in the eye, iris and / or pupil.

[0021] It will be appreciated that one or more embodiments can be used to monitor treatment outcomes. For example, once a treatment has been started (e.g. surgical, medical or physiotherapy), embodiments can be used to monitor the effect, progress or outcome of the treatment.

[0022] In particular, one or more embodiments can optionally be used for remote patient monitoring (RPM) to assess one or more episodes of dizziness, such as associated with balance problems associated with the vestibular system in the inner ear, vestibular pathways or the central nervous system.

[0023] An aspect of the present invention provides an apparatus or method for personal use in capturing eye or pupil movement as an indicator for assessment of a medical condition of a patient, the apparatus including eye / pupil motion imaging means, eye / pupil motion recording means, and at least one activation means.

[0024] The at least one activation means can be configured for a patient to self-initiate operation of the apparatus, such as on demand, to record their eye or pupildata, such as one or more pupil features (e.g. pupil size, dilation and / or shape), and / or eye / pupil movement, during an episode of dizziness.

[0025] Embodiments may include the apparatus, when in the possession of a user / patient for use in recording their eye / pupil data, is set up in a ready state (standby). The ready state may include a power on state of the apparatus awaiting activation of recording self-initiated by the user. The ready state may be a low energy use state and / or may enable the apparatus to communicate with, and / or be communicated to from, a remote location, such as by wireless communication, remote server, cloud data communication.

[0026] The apparatus may include instigation means configured to instigate operation of the apparatus prior to commencing recording. The instigated operation of the apparatus prepares the apparatus to make a recording.

[0027] The instigation means may be configured to receive input from motion sensing means arranged and configured to detect movement of the apparatus, and the apparatus processing means to instigate operation of the apparatus based on the sensed motion.

[0028] The motion sensing means may include at least one accelerometer configured to detect change in orientation, rotation and / or translation of the apparatus to instigating the operation.

[0029] An initial operation (e.g. by device movement detected by accelerometer) may may the devices core processor (e.g. System-on-module) in order to facilitate quicker start up time to the record state, with the instigation operation of the start recording being activated by a second activation means (e.g. button press).

[0030] According to one or more embodiments, if the at least one activation means is not operated within a predetermined period after said instigation of operation of the apparatus, the apparatus is configured to return to the ready (standby) state.

[0031] The apparatus may be calibrated and / or configured for self-use by the patient, and configured to complete a recording session and send recorded data to a remote location or cloud storage for subsequent review without requiring the patient’s functional input to the apparatus beyond the patient’s self-initiated operation of the apparatus.

[0032] The at least one activation means may include at least one input device, preferably just one input device.

[0033] Embodiments may include commencing recording an episode once the user operates at least one activation means, such as s single activation or input device, such as a single press button.

[0034] Embodiments may include commencing recording an episode when the apparatus is grasped in both hands by the user and / or when light is excluded by application of the device to the user’s face.

[0035] The apparatus can include one or more user contact sensors and / or one or more switches, such as by holding the apparatus in a certain orientation or at one or more particular parts / locations of the apparatus e.g. grasping either end / side, to activate the apparatus to commence eye / pupil movement recording.

[0036] The apparatus may activate upon being held at a particular orientation or moved through a pattern of orientations, such as tilting then levelling.

[0037] The apparatus may activate by voice command, which optionally may only work when the user is holding the apparatus, such as in both hands and / or to their face, to commence recording, to help prevent inadvertent voice command operation.

[0038] The apparatus may conduct eye feature recognition before commencing recording, to check that the user is the correct user and / or that the device is correctly placed.

[0039] Accelerometer data can be used to determine that the apparatus has been, or is in motion, such that the device is being moved to or applied to the user’s face. The pattern of accelerometer data can be used to check the apparatus is to commence recording.

[0040] Prior to commencing recording eye / pupil movement, the apparatus may check at least one feature of the eye(s), such as shape, colour, iris feature(s) e.g. iris shape, veins, patterns, iris to sclera (white of the eye) proportion(s), pupil shape, position, dilation, separation. Such a check can be to ensure that the user is the correct user for the study. Iris features of the eye can include ocular biometric markers, such astextures, colours, fibre arrangements in the iris, pigmented rings, crypts (holes), and / or furrows (grooves).

[0041] Embodiments may include an apparatus and / or method of use of an apparatus for personal use in capturing eye or pupil movement as an indicator for assessment of a medical condition of a patient, the apparatus including eye and / or pupil motion imaging means, eye and / or pupil motion recording means, and at least one activation means, such as an input device, for initiating an operation of the apparatus, the activation means or input device configured to provide selective functional control of the apparatus based on selective operation of the input device.

[0042] Embodiments may include an apparatus for personal use in capturing eye or pupil movement as an indicator for assessment of a medical condition of a patient, the apparatus including eye / pupil motion imaging means, eye / pupil motion recording means, and at least one activation means, such as an input device, configured for a patient to self-initiate operation of the apparatus on demand by operation of the activation means / input device to record their eye or pupil movement during an episode of dizziness, wherein the apparatus is calibrated and / or configured for self-use by the patient and configured to complete recording the session and send the recorded data to a remote location or cloud storage for subsequent review without requiring the patient’s functional input to the apparatus beyond the patient’s self-initiated operation of the apparatus.

[0043] Embodiments may include an apparatus for personal use in capturing eye or pupil movement as an indicator for assessment of a medical condition of a patient, the apparatus including eye / pupil motion imaging means, eye / pupil motion recording means, and at least one activation means / input device configured for a patient to selfinitiate operation of the apparatus by a single operation of the activation means / input device to commence the apparatus recording their eye or pupil movement during an episode of dizziness, the apparatus configured to complete recording the session and send the recorded data to a remote location or cloud storage for subsequent review without requiring the patient’s functional input to the apparatus beyond the patient’s single operation of the apparatus.

[0044] Embodiments of the apparatus may be calibrated and / or configured (e.g. pre-calibrated and / or configured) to that patient self-use by the patient. Apparatus calibration and / or configuration may include at least one of: frame positioning(windowing), apparatus positioning (correct position on user’s face / head) and / or gaze positioning / pupil position (adjusting / compensating for angle of gaze).

[0045] One or more embodiments may provide the apparatus including the activation means / input device, preferably being or including a primary input device, such as a button, operable by a user, such as a wearer of the apparatus and / or a medical practitioner or clinician.

[0046] According to one or more embodiments, the apparatus is personally useable by user, such as a patient, applying the apparatus directly to their own face to cover their eyes. The user, such as a patient, can hand-hold the apparatus to their own face, covering their eyes with the apparatus. Such handholding of the apparatus can help to steady the apparatus.

[0047] The apparatus may be retained to the user’s head by a retainer, such as a strap or harness. However, it will be appreciated that one or more embodiments can be retained to the user’s face by the user holding the apparatus onto their face to cover their eyes without the use of a retainer or other head support.

[0048] Providing one or more embodiments of a hand-held apparatus of the present invention not requiring a head strap / harness provides the patient with greater personal control and safety.

[0049] Episodes can be so severe and sudden that patients do not have time or capability to manage a head restraint and / or complex or time-consuming device connectivity for data transfer or manual operation of controls of such an apparatus. Consequently, it is beneficial that embodiments of the present invention enable a user to and hold the apparatus to their own face, covering their eyes with the apparatus, and operating the activation means or input device that puts the apparatus into a functional recording and data transfer mode to record the episode and transmit the data for assessment without needing further input by the user.

[0050] One or more embodiments of the present invention includes an apparatus for personal use in capturing eye data or pupil data or eye / pupil movement as an indicator for assessment, such as for informing assessment of a medical condition of a patient.

[0051] The apparatus may include eye motion imaging means, eye motion recording means, and an input device configured for a patient to self-initiate operation of the apparatus by a single operation of the input device to commence the apparatus recording their eye or pupil movement during an episode of dizziness.

[0052] Embodiments may include the apparatus pre-calibrated and / or configured (such as by the clinician) prior to the apparatus being issued to the patient. The apparatus may store onboard calibration and / or configuration settings / parameters for that patient. Pre-calibration and / or configuration can include alignment of the apparatus relative to the particular patient’s facial features and / or eyes / pupils. Calibration and / or configuration settings / parameters for a particular patient can be replaced with calibration and / or configuration settings / parameters for another patient prior to the apparatus being issued to that other patient e.g. after a study has concluded with the first mentioned patient.

[0053] Embodiments may include the apparatus having inbuilt calibration and / or configuration / self-calibration and / or configuration and / or set-up.

[0054] The input device may be configured to provide selective functional control of the apparatus based on selective operation of the activation means or input device.

[0055] The activation means / input device may be configured to activate or select from operational modes or functions of the apparatus.

[0056] The activation means or input device may be arranged and configured to direct the apparatus to enter into one of the multiple operational modes and / or functional states. Preferably, each functional state may be a subset within a particular operational mode. Embodiments of the single operation of the activation means / input device may include a single press of a button of the apparatus. The apparatus may have a single button or control for all operational states required by the user / patient.

[0057] It will be appreciated that the activation means, such as a single input device, of the apparatus for operation by the patient, the patient sensing onset or during onset of an episode, that initiates recording eye / pupil data, enabling the apparatus to do one or more of: ensure calibration and / or configuration and alignment with the user’s / patient’s eyes, making a recording, and process (partially or fully) data to ensurequality, complete recording the session, and send the recorded data to a remote location or cloud storage for subsequent review and analysis, provides significant improvement over known practices.

[0058] Patients suffering onset of an episode of dizziness, or during such an episode, are known to be unable to operate multiple functions, set up devices or establish data connections. Consequently, the apparatus being pre-configured (such as set-up and calibrated and / or configured for the patient by the clinician prior to, or at the time of, issuing the apparatus to the patient) for the patient to use themselves with a single operational input helps to ensure accurate recording of eye / pupil movement during an episode (such as an episode of dizziness, nystagmus, vertigo or neurological disorder).

[0059] Set up and / or configuration for a particular user / patient can include initially establishing one or more eye and / or facial features or information of the user / patient, such as eye shape, relative eye positions, iris feature(s), sclera feature(s) etc. The apparatus may store user / patient eye / facial feature(s) to check prior to or during use / recording eye / pupil movement data that the user / patient is the correct one. The apparatus may cease recording and / or send an alert, if the incorrect user / patient is detected or the check is inconclusive.

[0060] Embodiments of the present invention may beneficially store calibration and / or configuration parameters onboard, which may be configured for a particular patient to which the apparatus is assigned. Such calibration and / or configuration parameters can be loaded onto the apparatus by a clinician and the apparatus issued to the patient.

[0061] The apparatus can also be configured to automatically record, process (if required) and transmit the eye / pupil movement recording to a remote location for subsequent analysis / assessment, without the patient needing carry out any setup or connection step(s).

[0062] When the patient subsequently senses an episode / attack (such as an episode of dizziness, nystagmus, vertigo or neurological disorder) at a remote location (e.g. at home, recreation or work), the patient does not need to take any other setup steps beyond placing the apparatus to cover their eyes and to commence recording.

[0063] Commencement of recording may be automatic (e.g. once the apparatus is picked up and placed covering the patient’s eyes). For example, the apparatus may sense lack of ambient light reaching the image capture means / cameras and / or shading of the space in front of the patient’s eyes by the device.

[0064] Embodiments include reducing the need for patient input to operation of a single input device, such as a button, and the apparatus subsequently autonomously capturing the eye / pupil movement recording, carry out any onboard (edge) processing, carry out self-calibration and / or configuration, and send recording data to a remote location (such as by wireless transmission e.g. via a mobile telephone network / communication system). Video processing onboard the apparatus may include eye closure and / or poor quality image alert. Processing onboard the apparatus may include video adjustment and / or centering (centring).

[0065] Embodiments of the apparatus may be configured to cease recording and automatically transmit recorded eye / pupil movement data remotely.

[0066] Embodiments of the apparatus may conclude recording when the patient operates the at least one activation means or input device, such as with a single operation. Such a single operation can include multiple sub-operations therein, such as the user grasping the apparatus with both hands and placing the apparatus to their face -e.g. which can be a check that the apparatus is being held, and light is being excluded from the eyes by the apparatus ready for recording eye / pupil movement data.

[0067] Embodiments may include the apparatus configured to cease recording if the apparatus is unable to detect at least one said pupil of the patient for a period of time (such as during patient eye closure).

[0068] Embodiments may include provision of a unique patient identifier and / or study identifier. Such identifier(s) can be assigned (such as data stamped) on / to the video recording (which may include location, time and / or date data of that recording). The unique identifier may be used instead of a patient name for personal data protection and security purposes. The unique identifier may also be provided to ensure the correct recording data is assigned to the patient and is uploaded to the correct clinic / remote storage.

[0069] Embodiments of the apparatus may include a hand-held device configured for the patient to hold to their own face to cover their eyes during a recording by the apparatus of eye movement during the episode. Embodiments include the apparatus being hand-held in use, preferably not having a head restraint strap or harness.

[0070] Embodiments of the apparatus may be configured to enter different operational modes or different functional states. For example, automatically - such as on completion of a recording session or from a recording state to a ready state, and / or based on single operations over short or longer periods of activation of the at least one activation means or input device or multiple consecutive activations.

[0071] One or more embodiments of the present invention include a method of obtaining a recording of a patient’s eye / pupil motion for use in assessing health condition of the patient.

[0072] Embodiment may provide the method including patient self-initiated operation of the apparatus, the apparatus recording patient eye / pupil movement by operation of the single activation means / input device, and the apparatus automatically sending the recorded data to a remote location for subsequent analysis.

[0073] The at least one activation means or input device may be configured to activate or select from operational modes or functions of the apparatus. It will be appreciated that the activation means / input device may be arranged and configured to direct the apparatus to enter into one of the multiple operational modes and / or functional states.

[0074] The at least one activation means or input device may be a multifunction single input device. For example, a single control or button having differing functions based on one or more of a number of immediately sequential operations or timing pattern of operations.

[0075] The apparatus and / or method may include self-calibration and / or configuration and eye / pupil alignment assessment with the patient’s eyes / pupils prior to and / or during the recording.

[0076] Embodiments may include a method of obtaining a recording of a patient’s eye motion for use in assessing health condition of the patient, the methodincluding: patient self-initiated operation of the apparatus of any one of the preceding claims, the apparatus calibrated and / or configured for self-use by the patient, the apparatus recording patient eye and / or pupil movement by operation of the activation means or input device, and the apparatus automatically sending the recorded data to a remote location for subsequent analysis.

[0077] Embodiments may include the apparatus configured to complete recording the session, ensure calibration and / or configuration and alignment with the patient’s eyes / pupils, and send the recorded data to a remote location or cloud storage for subsequent review, without requiring the patient’s functional input to the apparatus beyond the patient’s single operation of the apparatus.

[0078] Apparatus calibration and / or configuration may include at least one of: frame positioning or windowing, apparatus positioning and / or gaze positioning / pupil position. The calibration and / or configuration includes one or more of: adjusting / compensating for angle of gaze, adjusting / compensating for focus and / or adjusting / compensating for illumination.

[0079] Embodiments may include calibrating and / or configuring the apparatus (e.g. pre-calibrated and / or configured) to that patient for self-use of the apparatus by the patient.

[0080] Apparatus calibration and / or configuration may include at least one of: frame positioning (windowing), apparatus positioning (e.g. correct position on user’s face / head), gaze positioning / pupil position (e.g. adjusting / compensating for angle of gaze, and / or for focus or for illumination.

[0081] As noted above, international patent application PCT / AU2021 / 050398, published as WO2021 / 217218, by the present applicant is incorporated herein in its entirety by reference.

[0082] The method may include the apparatus self-calibrating and / or configuring, compensating, configuring and / or assessing alignment with the patient’s eyes / pupils. Embodiments may include the apparatus making required adjustments before, during or after recording an episode of eye / pupil motion.

[0083] The method may include ceasing recording if sufficient external light is detected entering into a space within the apparatus between at least one image capture means and the patient’s pupils.

[0084] The apparatus may be configured to cease or pause recording if the patient closes their eyes during recording. The apparatus may recommence recording if the patient reopens their eyes within a predetermined period, such as within a predetermined period since recording was paused or since the patient closed their eyes. The apparatus may have a time threshold whereby recording continues for a period after eye closure is detected, and may cease / pause recording only after a period elapses (e.g. allowing for long eye blink periods). One or more said periods may be several seconds, e.g. 5-10 seconds.

[0085] The method may include the apparatus automatically transmitting the recorded eye / pupil movement data remotely either during the recording or after the recording, or a combination of both.

[0086] The method may include the apparatus concluding recording when the patient again operates the activation means or input device.

[0087] Embodiments may have at least two operational modes: 1. In-Study (Patient) mode and 2. Not-in-Study mode. When operational to gather data, i.e. not powered down the apparatus will preferably be in one or other of the operational modes.

[0088] One or more of a number of functional states may be a subset within a particular operational mode. It will be understood that each of the multiple modes can possibly be in or allow a choice of a number of different said functional states. For example, each of two modes may allow the apparatus to be in one of a number of functional states within the chosen mode.

[0089] It will be appreciated that one or more embodiments of the present invention may have a single button on the apparatus for patient operation, such as to simplify operation for the patient during onset or when experiencing an episode or attack, and / or to avoid risk of the patient otherwise having the apparatus performing functions that are not intended for them and / or avoiding the patient accidently turning off the apparatus that would otherwise affect start up time and risk missing valuable recording time.

[0090] Embodiments may enable operation of the activation means or input device for single or multiple activations. One or multiple activations may be for relatively short or longer periods thereof. Thus, multiple consecutive activations can enter the apparatus into different function modes (or status) of operation. From a user’s perspective i.e. a patient personally using the apparatus, embodiments of the apparatus include a single input device operation to put the apparatus into recording mode without the need for further involvement by the patient.

[0091] The patient can press a single button once, and then hold the apparatus to their face, covering their eyes with the apparatus, and the apparatus will record eye / pupil motion, carry out any onboard processing (such as video compression), and send the recording to a remote location (such as cloud storage) via a wireless data network, such as a mobile telephone network. A particular functional state may only occur in one or other of the modes; however, one or more of the functional states may occur in more than one of the choices of operational modes.

[0092] Embodiments may enable the apparatus to be in more than one functional state at a time, however, some functional states are mutually exclusive, such as OFF and RECORDING (e.g. the apparatus cannot be both powered off when not in use and in use recording data). See, for example, Table 1 below and Figure 6.

[0093] Figure 6 shows a visual representation of overall states including IN STUDY (with patient) and NOT IN STUDY (not with patient) operational modes and the relevant functional states, e.g. see Table 1 above, according to one or more embodiments of the present invention.

[0094] One or more embodiments may include an IN-STUDY operational mode wherein, when the apparatus has been assigned to a patient (preferably having a unique patient identifier (patient ID)) associated with and / or stored in the apparatus. It will be appreciated that apparatus initial setup for a patient could just be assigning the apparatus to that patient, or it could be assignment to that patient and further configuration, such as framing calibration and / or instructions to the patient on how to use the apparatus. See video frame / framing setup configuration below.

[0095] A video frame (framing) can be set for that patient, such as by the clinician configuring the apparatus for that particular patient. For example, framing for any one or more of:• face and / or eye position for comfort of use,• light exclusion around the face-apparatus interface,• correct hand hold of the apparatus by the patient,• correct calibration and / or configuration / framing of the internal image recording devices, such as cameras, with respect to the patient’s eyes, within the apparatus.

[0096] The apparatus may then be ready to record episode / session data when needed.

[0097] During setup configuration (SETUP state), one or more embodiments of the apparatus may be arranged and configured to temporarily store the unique patientidentifier (patient ID) but during the setup procedure the apparatus will still be in NOT-IN-STUDY mode.

[0098] One or more steps can be taken to change between the modes. For example, the setup configuration procedure can be completed prior to commencing the IN-STUDY mode. To change from IN-STUDY mode to NOT-IN-STUDY mode, there can be notification communicated / transmitted to the apparatus, such as from the clinician / clinic.

[0099] An ‘End-study’ procedure can have a number of steps. This can include selecting the study to be closed and checking whether the apparatus has been returned by the patient to the clinic. The returned apparatus can be connected in communication with an information system (such as by operation of the activation means or single input device / button / control on the apparatus). The information system can instruct the apparatus to end the study and upload stored patient data, and then the apparatus can shut itself down. The information system can include an offboard electronic information system (RIS or IS), such as an in clinic electronic information system storing patient records.

[0100] Preferably, setup configuration is completed, the unique patient identifier (patient ID) remains stored in or associated with the particular apparatus assigned to that patient for that study, and the apparatus becomes in IN-STUDY operational mode. Preferably, if the setup procedure is not completed, the unique patient identifier is removed from the apparatus (e.g. for the apparatus to be used for a different patient or to be freshly setup for the same patient).

[0101] RECORDING State: Preferably, recording can only occur during an IN-STUDY mode, e.g. when the apparatus is assigned to a particular user / patient.

[0102] Embodiments may include commencing recording an episode once the user operates at least one activation means, such as s single activation or input device, such as a single press button.

[0103] Embodiments may include commencing recording an episode when the apparatus is grasped in both hands by the user and / or when light is excluded by application of the device to the user’s face.

[0104] The apparatus can include one or more user contact sensors and / or one or more switches, such as by holding the device in a certain orientation or at one or more particular parts / locations of the device e.g. grasping either end / side, to activate the apparatus to commence eye / pupil movement recording.

[0105] The apparatus may activate upon being held at a particular orientation or moved through a pattern of orientations, such as tilting then levelling.

[0106] The apparatus may activate by voice command, which optionally may only work when the user is holding the apparatus, such as in both hands and / or to their face, to commence recording, to help prevent inadvertent voice command operation.

[0107] The apparatus may conduct eye feature recognition before commencing recording to check that the user is the correct user.

[0108] Accelerometer output(s) / data can be used to determine that the apparatus has been, or is in motion, such that the device is being moved to or applied to the user’s face. The pattern of accelerometer data can be used to check the apparatus is to commence recording.

[0109] Accelerometer output(s) / data can be used to start processes on the apparatus / device e.g. start processor device (System-on-Module), such as in anticipation of change of state of the apparatus e.g. from ready state to recording state.

[0110] Prior to commencing recording eye / pupil movement, the apparatus may check at least one feature of the eye(s), such as shape, colour, iris feature(s) e.g. iris shape, veins, patterns, iris to sclera (white of the eye) proportion(s), pupil shape, dilation, size. Such a check can be to ensure that the user is the correct user for the study. Iris features of the eye can include ocular biometric markers, such as textures, colours, fibre arrangements in the iris, pigmented rings, crypts (holes), and / or furrows (grooves).

[0111] Immediately prior to or during an onset of an episode (such as an episode of dizziness), preferably the patient can activate the apparatus, such as by operating the single input device and hold the apparatus to their face, covering, and thereby blocking out external light to, their eyes with the apparatus.

[0112] One or more embodiments may include indicating recording underway during the RECORDING state, such as by illuminating a visual indicator, which may include flashing a light source (such as a blue light), which may be incorporated into the input device (such as an illuminated button). Thus, the input device can act as a start recording button with a particular indication associated with the RECORDING functional state during IN-STUDY operational mode. An audible sound may be associated with the light indication. The RECORDING state can preferably only occur when the apparatus is in IN-STUDY mode.

[0113] READY State: Preferably, one or more embodiments may include indicating the READY functional state (e.g. when the apparatus is in IN-STUDY operational mode) denoted by a different visual indication than for the RECORDING functional state 108, such as by a different colour indicator than that for the RECORDING functional state. For example, the input device may illuminate with a different colour or colour pattern (flashing pattern). The READY functional state can preferably only occur when the apparatus is in IN-STUDY operational mode.

[0114] The apparatus may include an in IN-STUDY operational mode indicator / indication, such as an IN-STUDY operational mode light.

[0115] It will be understood that the READY functional state may be a base state when the apparatus has battery charge / power and is IN-STUDY operational mode. Preferably, the apparatus cannot be in the READY functional state if 1. the apparatus is charging onboard batteries (CHARGE state); 2. the apparatus is in FAULT functional state; or 3. the apparatus is in OFF functional state.

[0116] STORE state: When the apparatus has successfully finished recording data of a patient episode during a session, such as eye motion data and optionally apparatus motion / position data captured during a dizzy spell of the patient. The recorded data can be stored by the apparatus internally or remotely / offboard, or a combination of both. The apparatus can therefore enter a STORE functional state, which can be denoted by a Storage indicator, such as a lit icon, on the apparatus. Once the recorded data has been transferred remote from the apparatus, such as to be stored on servers in off-site locations e.g. ‘in the cloud’, that recorded data can be deleted from the apparatus storage and the Storage indicator will no longer be lit. It will be appreciated the apparatus may store data recorded from multiple sessions / episodes for the samepatient, which data may be transferred as multiple session recordings (e.g. in the case that no 4G or Wi-Fi wireless communications network is available for data transfer when each respective recording is created, and the patient has suffered / recorded multiple episodes). If the onboard storage is becoming full, preferably the Storage indicator provides a relevant indication, such as flashing to draw attention.

[0117] IN-CLINIC state: The state occurs when the clinician forces the apparatus to be connect to the electronic information system (RIS) (apparatus in INSTUDY or NOT-IN-STUDY functional state) or when the apparatus is turned on from an OFF functional state while in NOT-IN-STUDY state. It will be appreciated that the apparatus may also connect to the electronic information system (RIS) at other times (e.g. at the end of recording) when not in the IN-CLINIC functional state.

[0118] CHARGE state: This functional state occurs when the apparatus is electrically charging an onboard power source, such as batteries, e.g. charging via a USB or other power connection. The CHARGE (CHARGING) functional state can occur during either of the IN-STUDY or NOT-IN-STUDY operational modes.

[0119] Preferably, if the apparatus is battery charging in IN-STUDY operational mode, the apparatus is not, or cannot be, in the RECORDING functional state 108. That is, the patient would have the apparatus not charging during use in order to record an episode of dizziness, thus providing an advantageous safety feature for the patient.

[0120] It will be appreciated that the overall states encompass ‘in study’ and ‘not in study’ states / modes. For example, states of the apparatus when in study mode for use by a patient and when not in study mode e.g. when empty prior to use / deployment to a patient or in setup mode, such as by a clinician or health care professional.

[0121] EMPTY state: The apparatus can be in an EMPTY state, ready to use for a new patient, functional state. The apparatus can be ON with the CHARGE / CHARGING state indicator displayed. Preferably, no other indicators are lit -unless a warning / error (FAULT) functional state is also occurring. During the EMPTY functional state, the apparatus is preferably waiting for instruction / activation, such as when ready to be deployed for another patient / patient study.

[0122] It will be appreciated that embodiments may include at least one multifunctional activation means or input device.

[0123] For example, when the input device (such as an input button or ‘record’ button) is pressed twice (double press) in succession, the apparatus attempt to connect to the electronic information system (e.g. try for IN-CLINIC functional state). Other functionality of the input device is considered to fall within the scope of the present invention.

[0124] The at least one multi-functional activation means or input device may provide certain apparatus functionality access for the user / patient and other or further functionality access for the clinician or other healthcare professional supervising / overseeing use of the device for the assigned user / patient. Certain functionality of the at least one activation means or input device may be available to the user / patient, such as single press button function. The clinician or other healthcare professional may have knowledge enabling access to further functionality via the same at least one activation means or input device, such as operation patterns and / or, timing of or between operations of the at least one activation means or input device.

[0125] NOT-IN-STUDY operational mode can be used when the apparatus is not yet assigned to a particular patient i.e. prior to the apparatus being put into an INSTUDY mode.

[0126] Embodiments of the apparatus can be put into an EMPTY functional state, e.g. when in a NOT-IN-STUDY mode. EMPTY state occurs when the device has been turned on but is NOT-IN-STUDY and not in the setup state. The apparatus can attempt to connect to an electronic information system (e.g. RIS). By way of example, if no connection is made between the apparatus and the electronic information system for a period of time, such as 5 mins, the apparatus in an EMPTY state can return to the OFF functional state.

[0127] The apparatus may unintentionally or through patient intervention be positioned incorrectly on the face, and the video recording of eye position consequently taken at a non-optimal angle. As a result, the patterns / tracings may not be truly representative of the actual direction of the eye movement. One or more forms of the present invention includes position calibration and / or configuration on the user’s head / face.

[0128] Calibration and / or configuration (or compensation) refers to referencing a particular feature of the apparatus / method to a reference or creating a reference with which to base ongoing measurements, recording or use etc. The present invention encompasses various embodiments of calibration and / or configuration, as described herein, such as frame positioning (windowing), apparatus positioning (correct position on user’s face / head), and gaze positioning / pupil position (adjusting / compensating settings for angle of gaze, focus and / or illumination). Other forms of calibration and / or configuration or compensation are envisaged to fall within the scope of the present invention.

[0129] The apparatus may include a self-contained portable face cover for at least part of a wearer’s face including the eyes, such as a mask, goggles or glasses, for use in the investigation of one or more features (such as eye data, motion of the eye(s), motion of one or more eye or pupil features, position, shape, dilation, and / or changes in the eye or pupil), e.g. such as presented during nystagmus.

[0130] The apparatus may include: a light omitting cover for the eyes; a suitable light source to illuminate the wearer's eyes; a digital image sensor to capture images; a data processing unit for processing the captured images; a storage medium to record the processed images; and a communications port (wired and / or wireless) for communicating images and commands to an external receiver.

[0131] A method of using the apparatus to investigate changes of the eye is also encompassed within one or more forms of the present invention.

[0132] For example, one or more forms of the present invention may include a method of investigating changes in the eye using an apparatus according to one or more embodiments of the present invention that detects, measures and / or records eye movement, changes in the eye(s) or movement of features of the eye(s), the method including applying the apparatus, such as a face cover for at least part of the face including the eyes, to a wearer’s face (covering the eyes), capturing images of the wearer's eyes for a period of time after said applying the apparatus; and communicating the captured images from the apparatus to an external receiver for analysis or analysing the images within the apparatus, wherein such analysis of the images is for assessing or informing diagnosis, absence or presence of a disorder or medical condition.

[0133] Embodiments may include a method of obtaining a recording of a patient’s eye motion for use in assessing health condition of the patient, the method including: patient self-initiated operation of the apparatus of any one of the preceding claims, the apparatus calibrated and / or configured for self-use by the patient, the apparatus recording patient eye and / or pupil movement by operation of the input device, and the apparatus automatically sending the recorded data to a remote location for subsequent analysis.

[0134] Embodiments may include a method of obtaining a recording of a patient’s eye motion for use in assessing health condition of the patient, the method including: patient self-initiated operation of the apparatus of any one of the preceding claims, the apparatus recording patient eye and / or pupil movement by operation of the single input device, and the apparatus automatically sending the recorded data to a remote location for subsequent analysis.

[0135] The apparatus and / or method may be configured such that operation of the input device is a single press of a button of the apparatus or is an automatic operation of the input device when the patient puts the apparatus to their face. For example, the apparatus may autonomously / automatically detect reduction of light in the space between the apparatus and the patient’s face when the apparatus is brought to the patient’s face to cover their eyes and / or the apparatus may detect movement (being picked up) and / or a particular orientation

[0136] One or more forms of the present invention includes the apparatus self-calibrating and / or configuring for position of internal image capture means relative to the user’s / wearer’s eye and / or pupil position. The apparatus may be configured to conduct self-calibration and / or configuration after operation of the input device to initiate the apparatus recording eye / pupil movements and the apparatus actually commencing recording session data, such as for subsequent uploading to an electronic information system.

[0137] Such calibration and / or configuration may be conducted to determine the position of the pupil(s) of the user’s eye(s) relative to the apparatus. The position needs to be known so as when the pupil (s) move, the angular degrees of movement can be accurately determined. It will be appreciated that nystagmus are categorised by their speed and direction. Self-calibration and / or configuration of the apparatus can help toensure correct frame position (eyes / pupils correctly positioned for viewing / recording movement of the eyes and / or correct positioning of the apparatus on the user’s head / face and / or correct position within a sensor area of the image to be recorded).

[0138] At least one measurement means may be provided to measure one or more of environmental metrics, body metrics or head metrics, in addition to information / data obtained or derived from image capture information / data from the apparatus, to assess neurological and / or vestibular condition or activity.BRIEF DESCRIPTION OF THE DRAWINGS

[0139] One or more embodiments of the present invention will hereinafter be described with reference to the accompanying Figures, in which:

[0140] Figures 1 A and 1 B show examples of a user / patient experience flowchart according to one or more embodiments of the present invention.

[0141] Figure 2 shows an example of an IN-STUDY data capture / recording and recording send to cloud procedure for an apparatus according to one or more embodiments of the present invention.

[0142] Figures 3A and 3B show indicator and input device features of an apparatus according to one or more embodiments of the present invention.

[0143] Figure 4 shows an example of an apparatus according to one or more embodiments of the present invention, including image capture means, at least one onboard accelerometer to measure / capture head inclination and change of inclination, and data transmission means.

[0144] Figure 5 shows a visual representation of patient / user operational modes and the relevant functional states, according to one or more embodiments of the present invention.

[0145] Figure 6 shows a visual representation of overall states including IN STUDY (with patient) and NOT IN STUDY (not with patient) operational modes and the relevant functional states, see Table 1, according to one or more embodiments of the present invention.DESCRIPTION OF PREFERRED EMBODIMENT(S)

[0146] One or more embodiments of the present invention will hereinafter be described with reference to the drawings. In the following detailed description, reference is made to accompanying drawings which form a part of the detailed description. The illustrative embodiments described in the detailed description, depicted in the drawings and defined in the claims, are not intended to be limiting. Other embodiments may be utilised, and other changes may be made without departing from the spirit or scope of the subject matter presented.

[0147] It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are contemplated in this disclosure.

[0148] Embodiments can include an apparatus 10, or method for personal use of the apparatus, in capturing eye or pupil movement as an indicator for assessment of a medical condition of a patient.

[0149] The patient's eyes 13 can be illuminated by a light source 36, such as by one or more infrared LEDs, incorporated as part of / attached to / within the apparatus. This is so the wearer / user cannot fixate on any point, therefore overriding the spontaneous eye movements. During Recording, one or more image capture means 38, such as cameras / video cameras, (e.g. one for each eye, or a single camera and a mirror arrangement), record the patient’s eye movements (nystagmus) during an attack episode e.g. a vertigo attack or dizziness. Two lens(es) / cameras 32, 38 can record the eyes / eye features (e.g. movement). The video recordings are stored, such as on the data storage apparatus 40, which may preferably be located mounted within or on the apparatus 10. The data storage apparatus 40 may include a memory, such as an electronic data storage memory. It will be appreciated that data, such as video recordings, accelerometer data / values, patient data, location, time and date, length of time of use etc., may be stored as data on the apparatus, may be part processed and transmitted remotely, or may be unprocessed, and transmitted for remote data storage and / or remote processing / analysis.

[0150] Preferably, the data storage apparatus 40 may be connected for data transfer with electronic circuitry 42 controlling the apparatus. The recordings are preferably compressed and eye movements logged. Processing of the eye movementscan occur within / on-board the apparatus. Other data, such as the quality of the image, how long the pupil 13.1 was open, can be stored and can be analysed on the unit or transmitted to an electronic information system 56 to subsequently be analysed remote from the apparatus, such as at a clinic 58, or be analysed / assessed by a health care professional or clinician in real-time. Capture / recording of eye position / movement (optionally with head position / orientation measurements) can be transmitted to a remote location, such as the ‘cloud’ or remote server 54, to be part- processed, fully processed and / or stored there, and accessible for provision to the clinic / information system / clinician.

[0151] The apparatus can be battery powered, such as by an on-board battery 44 and / or can receive power through a power connection 46. Information / data 52 directly or indirectly from the apparatus 10 of one or more embodiments of the present invention can be combined with sensed information / data from one or more head orientation / motion / movement sensors 32 (such as one or more accelerometers), one or more body / body function sensors 34 and / or one or more external sensors 36, or a combination of any two or more thereof.

[0152] The apparatus can include at least one onboard sensor 50, such as at least one accelerometer to measure head inclination and / or head movement.Accelerometer data can be combined with eye motion measurements / data for a given recording. Accelerometer data can be compressed. Accelerometer data related to head movement can be provided as an input to understanding relationship between head movement and eye motion. Gravity (G) and / or changes in gravity (Gt) over time can be measured. At least one frame pulse can be provided during recording such that the accelerometer records accelerometer data in-synchronisation (in-sync) with the eye / pupil movement image recording e.g. see Fig 2 by way of example.

[0153] The image capture means may include a pair of lenses 32 to focus images of the user's eyes onto a pair of image sensors, such as sensors of cameras 38. One particular preferable requirement of the respective lens is to have a depth of field that will allow the eye image to be always in focus. As different users will have varying length between the lens and eye, the lens will usefully have a depth of field over this range. Another possibility is for the lenses 32 to use auto-focusing technology (such as autofocusing cameras 38) or to allow the focus to be adjusted by the wearer and / or a clinician.

[0154] The apparatus can include eye motion imaging means, eye motion recording means, and at least one activation means, such as an input device, for initiating an operation of the apparatus, the input device configured to provide selective functional control of the apparatus based on selective operation of the input device. The input device may be or be part of a user interface for a user to input commands to the apparatus.

[0155] One or more embodiments may provide the apparatus including the activation means / input device 14, preferably being a primary input device, such as a button or other trigger device, operable by a user, such as a wearer of the apparatus and / or a medical practitioner or clinician.

[0156] According to one or more embodiments, the apparatus is personally useable by user, such as a patient, applying the apparatus directly to their own face to cover their eyes 13. The apparatus may be retained to the user’s head by a retainer, such as a strap or harness. However, it will be appreciated that one or more embodiments can be retained to the user’s face by the user holding the apparatus onto their face to cover their eyes 13 without the use of a retainer or other head support.

[0157] Recording 108: When the activation means / input device 14 (e.g. input button) is pressed, apparatus 10 may provide a start indication, such as by illuminating or changing illumination of a visual indicator 20 and / or playing a brief start tune or other audible indication, which can notify the clinician patient that the apparatus will start recording data. Embodiments of the apparatus 10 may actually start recording data immediately, or after a period has elapsed, such as between 5 and 30 seconds, preferably between 10 and 20 seconds, after the input device 14 is operated (e.g. button is pressed). When the data recording ends, the apparatus can give an audible indication, such as a distinctive sound, sound pattern or tune.

[0158] Eyes closure alert: When the apparatus does not detect a pupil in either eye i.e. due to one or both eyes being sufficiently closed, the apparatus can provide an audible and / or visual indication, such as a two-tone noise. One or both eyes being closed or partially closed to obscure the respective pupil can be detected via one or both image capture devices, such as internal camera(s) of the apparatus and onboard functional feature detection analysis determining a pupil detection confidence value.

[0159] For example, such an eye closure alert can be activated when pupil detection confidence remains below a confidence value, such as 0.8, in both eyes for more than 1 second. Return to normal recording can be indicated, such as by an audible signal, when the pupil detection confidence for either pupil is of a required value, e.g. at or above 0.8.

[0160] Snapshot: The apparatus can be arranged and configured to capture one or more images (such as snapshot images) of one or both pupils / eyes, and may provide an indication of such image capture, such as an audible indication. The captured image(s), such as snapshot images, may be sent separately or with the video data package such as to cloud storage and / or for remote review / processing for subsequent analysis.

[0161] By way of non-limiting examples exemplified in Figures 1A and 1B, the user can have possession of the apparatus 60, such as at home when active or sleeping, or travelling with them 62. When the study is completed or as otherwise necessary (such as for servicing), the apparatus can be returned 64 to the place of issue to the user or to another designated location.

[0162] The user can charge 66 the apparatus periodically, such as daily. An indication can be provided by the apparatus of charging state and / or fully charged.

[0163] When the user has, or senses the onset of, an episode of dizziness 68, the user takes the apparatus and commences a recording by placing the apparatus on their face, covering their eyes. The recording commences when the user self-initiates 70 the recording, such as by physical operation of the at least one activation means or input device 14.

[0164] The apparatus can provide an indication 72 to the user that the apparatus is recording, as confirmation and reassurance to the user that the apparatus is operating.

[0165] If the apparatus cannot record eye / pupil motion data, such as not being able to detect the eyes / pupils sufficiently or reliably (e.g. patient / user shuts their eyes or the apparatus is not positioned properly on them, the apparatus can give an audible alert 76.

[0166] During successful recording 74, the user keeps their eyes open 76.

[0167] After a recording period 78, e.g. 1-5 minutes, recording can end 80. Ending recording can be automatic after sufficient recording time has elapsed or after the user operates the at least one activation means or input device, such as a control button.

[0168] After recording, the user removes the apparatus from their face 82. If another recording is required 84, such as if the attack / episode is still continuing or the user foreshadows onset of a subsequent episode, the user can put the apparatus back to their face and re-activate recording 70.

[0169] As shown by way of further example in Figure 1 B, if light enters 75 the chamber between created between the user’s face / eyes and the recording means, the apparatus may give an alert 77, such as an audible warning. If light intrusion is removed 79, recording may recommence. However, if light enters for a sufficiently long predetermined period 87, the recording can be halted 80.

[0170] If the user shuts their eyes 81 during recording, the apparatus can give an alert 83 for the patient to re-open their eyes 85 and the apparatus can then recommence recording. However, if a pupil cannot be seen for a sufficiently long predetermined period 87, the recording can be halted 80.

[0171] Embodiments include multiple modes and states. The device 10 can be in an IN-STUDY mode 102 or a NOT-IN-STUDY mode 104. The overall states 100 encompass operational / functional states of the device within the IN-STUDY and NOT-IN-STUDY modes.

[0172] The one or more snapshots may be taken during SETUP STATE 106 when in the NOT-IN-STUDY mode 104. This allows for the clinician to view and set the recording frame during set-up (e.g. the snapshot represents the recording frame) and also allows comparison with video recording conducted during the IN-STUDY mode 102.

[0173] By way of example, snapshots can optionally be restricted to being taken only during the NOT-IN-STUDY mode 104 and never during the IN-STUDY mode 102. However, one or more snap-shot images may be taken and sent with video data collected during the IN-STUDY mode, or video is sent with one or more snapshot images created at calibration and / or configuration stage.

[0174] Once the setup procedure is complete, and the study has subsequently commenced, the IN-STUDY operational mode 102 starts.

[0175] A storage indicator light 22 may remain on, indicating that the apparatus has not successfully communicated with the electronic information system (to transfer stored recorded data) or has lost connection during communication of the data and some of the data remains stored on the apparatus.

[0176] Store / Send Data State: If the storage indicator is illuminated, there is session data stored (e.g. in data storage on the apparatus) or and / or data may be transmitted / sent and stored remotely.

[0177] If the storage indicator 22 has continuous illumination, it can be an indication that the apparatus has session data pending to upload or that session data upload is in progress (STORE functional state 116). The patient can still use the apparatus to record dizziness episode / session data during this time. If the storage indicator is flashing, then the apparatus onboard data storage is near full. Once the onboard data storage is full, the apparatus may not enable the RECORDING functional state 108, and the visual indicator associated with the RECORDING functional state 108 will not be illuminated or may show a data storage full indication (such as a particular colour or flashing / pattern of illumination). The FAULT functional state 112 visual indicator may optionally illuminate.

[0178] The storage indicator 22 may be illuminated if one or more recordings / sessions are stored on the apparatus that have not yet been sent remotely e.g. to the cloud. Once the one or more recordings / sessions are sent remotely, the storage indicator may be changed by the apparatus to unilluminated.

[0179] Preferably, the apparatus will normally be in a ready state 110 of operation when the apparatus is issued to a user, such that the apparatus promptly commences recording when the user senses an oncoming episode, or during an episode, of dizziness. The apparatus being in a ready state avoids the time delay of commencing from a fully OFF shutdown state when the user needs the apparatus to operate rapidly due to the often-debilitating effect of the dizziness.

[0180] In the ready state, the apparatus may be able to communicate with a remote location, such as for data uploading to the cloud / remote server, prompting data uploads and function checking of the apparatus.

[0181] The standby / ready state may provide a power indication to the user, such as one or more visual indications, e.g. one or more lights.

[0182] Ready to Record. It will be appreciated from the aforementioned that one or more embodiments of the present invention has to be in the IN-STUDY operational mode 102 and in the READY functional state 110 to record episode / session data when the patient experiences dizziness and uses the apparatus. The patient will be aware that the apparatus is ready to record by a visual indicator being lit e.g. solid green illumination of a visual indicator 20. This visual indicator will not be solid lit (e.g. or flashing and / or turns a different colour) when the apparatus is not ready to record.

[0183] Embodiments may include the apparatus not being ready to record (the ready to record visual indicator 20 will NOT be lit) if one or more of the following occurs:• The apparatus is not IN-STUDY operational mode 102;• The apparatus is already recording a session (indicator light will be flashing); • The apparatus is not ready to record due to a very small window of time after a previous recording;• The apparatus is in the FAULT functional state 112;• The apparatus has a full data storage (which may be denoted by the storage indicator illuminated / flashing and the FAULT functional state 112 on);• There is insufficient onboard battery charge remaining to make a recording, such as a 2-minute recording;• The charging / USB cable is connected to the apparatus;• The apparatus has had a request to end the study but is in the process of uploading remaining data / videos before the apparatus leaves the study;• The apparatus is in the OFF functional state 114.

[0184] End Study. If the clinician wishes to end a patient study (‘IN-STUDY’) operation of the apparatus, they can do so whether they physically have the apparatus on hand or not. IN-STUDY mode 102 can be ended remotely, such as if the device islost or stolen or if the patient has had the apparatus too long and is unable or unwilling to release or return it to the clinic. To shut down the study, the clinician can use an ‘end study’ function from a remote system control. The apparatus cannot be selected for another patient until all captured session data has been uploaded from the apparatus, and the patient ID is removed from the apparatus. The apparatus will change from INSTUDY to NOT-IN-STUDY operational mode (the relevant indicator will turn off). Once the process is finished and the apparatus becomes in NOT-IN-STUDY operational mode 104 then the apparatus can be configured as “Unassigned”, available to deploy to another user / patient.

[0185] By way of example, a suitable operator, such as clinician, or other healthcare professional, can initiate pre-calibration and / or configuration setup for that the user / patient such that the apparatus stores calibration and / or configuration settings / parameters for that patient.

[0186] The operator then operates the apparatus to take a wide-angle picture of the eyes using the image capture means (e.g. cameras) within the apparatus. The apparatus can provide an indication that it is taking a picture. The operator can select a cropped frame of the picture and prompts another photo to be taken. The apparatus indicates that it has taken another picture. If the positioning is correct, the study can commence (IN-STUDY mode). If the picture shows incorrect apparatus positioning relative to the user’s / patient’s eyes, the image capture calibration and / or configuration process can be rerun until satisfactory apparatus fit and positioning is achieved.

[0187] Once the study is started via the operating software, the IN-STUDY visual indicator 24 will indicate that the apparatus is ready to record data. The patient’s calibration and / or configuration parameters are stored in the apparatus. The clinician can go through an example recording with the patient. The patient leaves with the apparatus to use when experiencing an episode of dizziness at home, at work or at other places beyond the issuing clinic. The apparatus can automatically utilise the stored pre-calibration and / or configuration settings / parameters.

[0188] If the sensed eye / pupil position and / or motion during commencement of a new recording does not correspond with the pre-calibration and / or configuration settings / parameters, the apparatus may conduct calibration and / or configuration to compensate in order to obtain an accurate recording.

[0189] Exemplary embodiments:

[0190] The user / patient has the apparatus (that is charged) and in the IN-STUDY operational mode 102 (IN-STUDY visual indicator 24 illuminates):1. The apparatus is also in the READY functional state 110 (the input device visual indicator 20 is solid illuminated).2. The patient operates input device 14 (e.g. presses single button). The apparatus provides an indication (e.g. visual and / or audible) that it is commencing recording. The apparatus can provide a periodic intermittent indication (such as every second) after commencing recording to indicate that it is still recording.3. The patient puts the apparatus to their face, covering their eyes. An interface portion 28 of the apparatus can include a face conforming resilient material to form an exterior light excluding seal between the apparatus and the face around the patient’s eyes, such as a foam or other resilient material, such as a silicon rubber material, or combinations thereof.4. If the image capture means of the apparatus cannot detect a pupil (e.g. if the patient shut their eyes) during the recording, the apparatus will provide an audible indication, such as a downward two-tone noise, periodically (e.g. every second) until the image capture means find a pupil.5. After sufficient time, such as between 2 to 5 minutes, or if the activation means or input device is operated beforehand, the session recording will automatically end. The apparatus will provide an audible indication indicating the session recording is finished.6. The apparatus will go back to the READY functional state 110 (input device visual indicator 20 changes to a READY indication colour).

[0191] Example of User Instructions:

[0192] For the patient - Ready for Use:1. The apparatus issued to the patient is provided in the IN-STUDY operational mode 102 and READY functional state 110, ready to record symptoms at any time. The IN-STUDY visual indicator 24 indicates that the apparatus is assigned to the patient and ready to record. The input device indicator 20 indicates that apparatus is in READYmode and waiting for the patient to commence recording session data by operating input device 14. Embodiments can include one single press of input device 14 by the patient to commence the recording.2. If the input device visual indicator is not illuminated, the apparatus is not ready to record, such as due to insufficient power or full data storage from previous recordings not yet uploaded to the offboard / remote electronic information system. If the charge state visual indicator 16 indicates low charge state, such as 25% (one ‘bar’) power, the apparatus should be recharged before taking a next recording. If the Fault visual indicator 26 is providing a visual indication, such as flashing (e.g. flashing yellow) the data storage on the apparatus is likely full. Moving the apparatus closer to a wireless network or other wireless communications connection should enable the apparatus to wirelessly transmit the previously recorded data stored on the apparatus to the electronic information system for remote storage or return the apparatus to the clinic for uploading the recorded data. Once this has happened then the fault visual indicator turns off and the input device visual indicator 20 provides a READY visual indication, such as a green light.

[0193] For the patient - Starting a Recording:1. A recording can be started anytime the input device visual indicator is on indicating a READY functional state (such as a solid green light).2. To start a recording, the patient simply operates the activation means or input device 14 and places the apparatus against their face, covering their eyes with the apparatus.3. The activation means or input device visual indicator can start flashing and / or change colour. The visual indicator can be blue, green or another colour, which can change. The apparatus can optionally, instead or also, provide an audible indication that recording has commenced, such as playing a tune. The patient then knows that the recording is underway while they are preparing to put the apparatus over their eyes or when they have the apparatus over their eyes and excluding exterior light from entering. For example, the apparatus can start the eye motion / position recordings a few seconds, such as 10s- 12s, preferably less than 12 seconds, more preferably 10 seconds or less, after the input device 14 is operated or it can be started straight away. A tune can play during this time. This allows ample time for the user / patient to sit or lie down in a safespace and see the visual indicator (e.g. green light) has been lit and start the recording and see the visual indicator flash and then to place the device correctly.

[0194] For the patient - During a Recording:1. During the session recording the eye motion data, the apparatus is placed to cover the patient’s eyes (can be held in place by the patient and / or use of a headband / strap). If the apparatus is placed on the patient’s face correctly there should be no external light entering the chamber 30 between the eyes and the image capture means (e.g. cameras within the chamber). The patient can adjust the apparatus on their face to create a better seal to their face.2. Optionally, the apparatus may provide an audible and / or visual indication (e.g. continuous noise / light or periodically / every few seconds) to let the user / patient know that the apparatus is still recording.3. A distinct alert audible signal may be given by the apparatus (such as descending beeps or ‘uh-oh’ noise), when the apparatus is indicating that it is not detecting the patient’s pupils (eyes may be closed or obscured or there is too much exterior light infiltrating into the chamber).

[0195] For the patient - End of the Recording: The apparatus may record eye motions for a predetermined period of time (such as two minutes). To stop the recording before the predetermined period elapses, the patient can operate the input device 20.

[0196] The recording may be automatically stopped if the apparatus has not been able to detect your pupils for a period, such as a number of seconds (see During a Recording).

[0197] When the recording ends, embodiments of the apparatus may provide an audible indication, such as playing a tune, and / or the input device visual indicator 20 (such as a green or blue lit button) will no longer be flashing, turn off or may change to another colour. Flashing visual indicator may indicate recording in progress. The visual indicator may go to being constantly lit or change colour when recording has completed / ceased.

[0198] For the patient - After the Recording:1. The input device visual indictor 20 will go back to indicate that it is not recording (e.g. being constantly lit) and the audible indication (if provided) will stop. Optionally, for a brief time the input device visual indication may turn off completely, indicating that the patient cannot commence another recording at this time (the apparatus may be processing / storing the recording data).2. Once the input device visual indication turns back to a solid READY indication, a fresh recording can be commenced. The storage visual indication may illuminate to indicate that the recording(s) has been stored and awaiting transmission to the electronic information system via a wireless communication connection.

[0199] Apparatus Fault or Study Ended:1. The Fault visual indication 26 can illuminate if the apparatus has an internal fault. The apparatus may no longer operate until the fault is cleared. That is, operation of the input device will no longer commence a recording. Function of the input device is disabled for the patient until the fault is cleared.2. The clinic / clinician overseeing the study can wirelessly transmit instructions to the patient’s assigned apparatus to end a study. Such instructions received by the apparatus may be indicated by the IN-STUDY visual indicator 24 not being lit. Reasons the clinic may want to end a study includes if sufficient quality data has been collected or the study period has ended, or if the apparatus has been reported missing to ensure no further recordings are made. Apparatus functional characteristics, such as state of charge, location, record of usage, may be obtainable from the apparatus by the clinic / clinician.

[0200] Being able to visualise the pattern (speed and direction) of nystagmus during an attack significantly aids in diagnosing the underlying cause of the attack. The present invention provides improved modality and user interface for capturing, measuring and / or displaying time of attack nystagmus and being able to view and present the pattern (speed and direction) significantly improves the assessment methodology.

[0201] It is important to have the apparatus correctly positioned on the patient’s head / face or to be able to determine position of the apparatus on the patient’s face and compensate for sub-optimal positioning to ensure useable / correct results.

[0202] The system allows for the day-to-day administration and collection of patient information. Stored information includes one or more of:• eye movement video sequences;• 3D orientation and position of the head during the episodes;• eye kinematics and tracking data;• Other eye feature information (e.g. pupil size);• history;• questionnaire data; and• information pertinent to diagnosis.

[0203] A software platform facilitates use of the apparatus and can help to identify patients for specific treatment options and enables research from the captured data including severity, timing and location of episodes.

[0204] In use, the apparatus captures video of the eye kinematics and preferably patient position (e.g. accelerometer, gyroscope) data.

[0205] Preferably, the apparatus may perform on-board processing that occurs during or after the video capture. The apparatus may include a processing unit configured to analyse captured image data for one or more anomalies, quality of image / data and / or for one or more event markers. For example, the on-board processing may detect if the patient closes their eyes during the recording and / or after the capture may process, such as compress, the video data and / or log particular events, such as variability in eye movement or eye closure or periods of non-movement between bouts of eye movement.

[0206] Preferably, the apparatus is configured to monitor the position of the pupil and adjust the recording frame, if necessary.

[0207] The captured data can be sent (streamed, sent in packets or sent as a whole) from the apparatus to a platform e.g. via hard wire or wireless, such as via a mobile phone network.

[0208] If a mobile network is not available, the apparatus can include the facility to store the data on-board to be downloaded e.g. at a later time (such as via USB, internal or removable storage).

[0209] Preferably, software on the platform is cloud based and accessed through a web-app.

[0210] By way of explanatory example, a patient can have custody of the apparatus permanently or for a time period. When the patient senses or begins experiencing an episode of dizziness, the patient puts on the apparatus and commences recording eye movements using the on-board image capture means.

[0211] The patient can receive a visual, audible and / or vibration alert that the apparatus is recording, started recording, or ended recording. If the patient shuts their eyes during recording or if ambient light enters the apparatus thereby affecting recording, the apparatus gives an alert to the patient.

[0212] If the eyes are closed and / or light entering continues for a period e.g. between 10 and 360 seconds, the recording can be halted / paused and the patient notified. Alternatively, if the apparatus successfully records eye movement images for a predetermined threshold period, say, between 30 and 360 seconds or between 60 and 120 seconds, the apparatus could indicate that successful recording is completed. The patient can cease recording. The captured image data is stored, processed on-board and / or sent for remote processing.

[0213] Embodiments may be configured such that the apparatus automatically ceases recording and automatically transmits the recorded eye / pupil movement data remotely.

[0214] Embodiments may be provided such that the apparatus is configured to conclude recording when the patient again operates the input device. Embodiments many be provided such that the apparatus is configured to cease recording if sufficient external light is detected entering into a space within the apparatus between at least one image capture means and the patient’s pupils. Embodiments may include the apparatus configured to cease recording if the apparatus is unable to detect at least one said pupil of the patient for a period of time.

[0215] With respect to the clinic side for deployment of the apparatus, a patient is instructed when and how to use the apparatus. After sufficient episode recordings are completed, the patient returns the apparatus to the clinician or, as otherwise arranged, keeps the apparatus.

[0216] Recorded data may be obtained directly from the apparatus (as processed data, semi-processed data for additional processing, or raw data for subsequent processing) and the obtained data is analysed. The image data can be transmitted from the apparatus for remote processing, such as by hard-wired, local wireless transmission e.g. Wi-Fi and / or mobile phone network link for remote processing and / or storage and / or analysis.

[0217] Episode recording may be monitored in real or near real time by clinicians, such as by automatic detection and transmission of recorded or direct image data as an episode occurs.

[0218] Embodiments may include a method of capturing and providing for assessment image data of eye / pupil movement during an episode of dizziness, such as set out by way of particular example in Figure 2.

[0219] The user, upon sensing onset of an episode of dizziness or during an episode of dizziness can start the device 10, such as by operating 200 a single button / input device 14 or by the device 10 sensing application to the user’s face and / or being held a certain way, such as by both hands.

[0220] However, it will be appreciated that such is a non-limiting example and that the apparatus may be activated to record eye / pupil motions by other activation characteristics, such as voice operation, facial / eye feature checking and automatic start up, or holding the apparatus to the face.

[0221] The device can boot up 202 (such as by booting up a processor device / SOM (System-on-Module). The device can have the processor device turn up to maximum processing speed 204 (this can help provide a pre-emptive warm up phase if the accelerometer detects it is about to be used). Recording, such as video recording, of eye / pupil movement can start 206 and video images can be recorded 208. The device 10 can conduct onboard video processing 210, such as providing an eye closure and / orpoor-quality image alert 212, and / or conduct video adjustment / pupil position centring 214.

[0222] Accelerometer data recording 222, 224 can commence and be conducted by the device in parallel with image capture / data video recording 208. Video compression 226 can be conducted, and the compressed video and accelerometer data can be recorded 228. Recorded data (image data and accelerometer data) can be packaged 230 for transmission 232 remotely, such as to the cloud.

[0223] Video recording and accelerometer data recording can end 216, such as after a set recording period or on deactivation of the device e.g. by the user pressing the input device to stop recording or by other means, such as releasing the device or placing in a particular orientation. The device can be made ready to record again 218 and return to standby after a period of non-use 220.

[0224] Embodiments of the present invention provides advantages of:• Reduced contact time with patients and increase the likelihood of arriving at a definitive diagnosis.• Ability to diagnose more patients due to (a) the reduced occurrence of repeat appointments with existing undiagnosed patients, and (b) shorter appointments with all patients.• Improved patient care.• Provides a source of income for the clinics.

[0225] Patients can use the apparatus themselves to record an episode or attack occurring remotely / away from the clinic (e.g. at home) even if they have low technology ability, have anxiety and / or other health, ability or wellbeing issues (e.g. poor tactile ability or ‘fear’ of technology). Having an apparatus with a single button to commence recording without needing additional setup time or steps helps to ensure usability and capture of valuable eye / pupil movement videos for assessment even if the patient has low technology awareness / ability and is suffering onset or during a debilitating episode / attack of dizziness or other neurological problem.The apparatus / system provides practical way of recording their spontaneous nystagmus, dizziness, or other neurological episode, when they occur away from the clinic. A singleinput device operation, only needing to hold the apparatus to their face (covering their eyes with the apparatus) and automatic eye motion recording, on-board data processing (edge processing) and transmission of the recording to a remote location for storage / analysis.

[0226] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

CLAIMS:

1. An apparatus for personal use in capturing eye or pupil data of a user, the apparatus including eye / pupil motion imaging means, eye / pupil motion recording means, and at least one activation means configured for the user to self-initiate operation of the apparatus on demand to record their eye or pupil movement during an episode of dizziness.

2. The apparatus of claim 1 , wherein the apparatus, when in the possession of a user / patient for use in recording their eye / pupil data, is set up in a ready state.

3. The apparatus of claim 2, wherein the ready state is a power on state of the apparatus awaiting activation of recording self-initiated by the user.

4. The apparatus of claim 2 or claim 3, wherein the ready state is a low energy use state.

5. The apparatus of any one of claims 1 to 4, wherein the apparatus has instigation means configured to instigate operation of the apparatus prior to commencing recording of the eye / pupil data.

6. The apparatus of claim 5, wherein the instigated operation of the apparatus prepares the apparatus to record the eye / pupil.

7. The apparatus of claim 5 or claim 6, wherein the instigation means is configured to receive input from motion sensing means arranged and configured to detect movement of the apparatus, and the apparatus processing means to instigate operation of the apparatus based on the sensed motion.

8. The apparatus of claim 7, wherein the motion sensing means includes at least one accelerometer configured to detect change in orientation, rotation and / or translation of the apparatus to instigating the operation.

9. The apparatus of any one of claims 6 to 8, wherein the instigated operation starts preparations to bring the apparatus from a ready state to a ready to record eye / pupil data state for the user to self-initiate recording of the eye / pupil data by activation of the at least one activation means.

10. The apparatus of any one of claims 5 to 9, wherein, if the at least one activation means is not operated within a predetermined period after said instigation of operation of the apparatus, the apparatus is configured to return to the ready state.

11. The apparatus of any one of the preceding claims, wherein the at least one activation means includes a single said activation means or input device or a single button / control.

12. The apparatus of any one of the preceding claims, the at least one activation means configured to activate recording an episode when the apparatus is grasped in both hands by the user and / or when light is excluded by application of the device to the user’s face.

13. The apparatus of any one of the preceding claims, the at least one activation means including one or more user contact sensors and / or one or more switches to activate the apparatus to commence eye / pupil movement recording.

14. The apparatus of any one of the preceding claims, including the at least one activation means configured to activate the recording when held in a certain orientation or at one or more particular parts / locations of the apparatus.

15. The apparatus of claim 14, wherein the at least one activation means is configured to commence the recording upon being held at a particular orientation or moved through a pattern of orientations.

16. The apparatus of any one of the preceding claims, the at least one activation means configured to activate the apparatus by voice command.

17. The apparatus of claim 16, wherein the voice command only effects commencing the recording when the apparatus detects the user is holding the apparatus.

18. The apparatus of claim 16 or claim 17, wherein the apparatus is configured to detect exterior light is excluded from the user’s / patient’s eyes by the apparatus before allowing the recording to commence based on the voice command.

19. The apparatus of any one of the preceding claims, wherein the apparatus is configured to conduct eye feature recognition before commencing the recording.

20. The apparatus of any one of the preceding claims, wherein the apparatus is calibrated and / or configured to facial and / or eye / pupil features of the user for dedicated self-use by the patient when the apparatus is in a study mode for that user.

21. The apparatus of claim 20, wherein said apparatus calibration and / or configuration includes at least one of: frame positioning or windowing, apparatus positioning, gaze positioning.

22. The apparatus of claim 20 or 21 , wherein the calibration and / or configuration includes one or more of: adjusting / compensating for angle of gaze, adjusting / compensating for focus and / or adjusting / compensating for illumination.

23. The apparatus of any one of the preceding claims, wherein the at least one activation means is configured to activate or select from operational modes or functions of the apparatus.

24. The apparatus of claim 23, wherein the at least one activation means is arranged and configured to direct the apparatus to enter into one of the multiple operational modes and / or functional states.

25. The apparatus of claim 24, wherein each functional state is subset within a particular operational said mode.

26. The apparatus of any one of the preceding claims, wherein operation of the at least one activation means is a single press of a button of the apparatus or automatic operation detected when the patient puts the apparatus to their face.

27. The apparatus of any one of the preceding claims, wherein the apparatus is configured to automatically cease recording and automatically transmit the recorded eye / pupil movement data remotely.

28. The apparatus of claim 28, wherein the apparatus is configured to conclude recording when the patient again operates the at least one activation means.

29. The apparatus of any one of the preceding claims, wherein the apparatus is configured to cease recording when the user removes the apparatus from their face and / or if sufficient external light is detected entering into a space within the apparatus between at least one image capture means and the patient’s pupils.

30. The apparatus of any one of the preceding claims, wherein the apparatus is configured to cease recording if the apparatus is unable to detect at least one eye feature or at least one said pupil of the patient for a period of time.

31. The apparatus of any one of the preceding claims, the apparatus configured to conduct self-calibration and / or configuration and eye / pupil alignment assessment with the patient’s eyes / pupils prior to and / or during the recording.

32. The apparatus of any preceding claim, wherein the apparatus includes a handheld device configured for the patient to hold to their own face to cover their eyes during the recording by the apparatus of the eye / pupil movement during the episode.

33. The apparatus of any one of the preceding claims, the apparatus being hand-held in use, not having a head restraint strap or harness.

34. The apparatus of any one of the preceding claims, wherein the apparatus is configured to enter different operational modes or different functional states based on single operations over short or longer periods of activation of the input device or multiple consecutive activations.

35. The apparatus of any one of the preceding claims, the input device configured as a multi-function input device.

36. The apparatus of claim 35, wherein the input device is configured as a single button having differing functions based on one or more of a number of immediately sequential operations or timing pattern of operations.

37. The apparatus of any one of the preceding claims, wherein the apparatus is configured to generate at least one frame pulse during recording such that an accelerometer records accelerometer data in-synchronisation (in-sync) with the eye / pupil movement image recording.

38. A method of obtaining a recording of a patient’s eye motion for use in assessing health condition of the patient, the method including: patient self-initiated operation of the apparatus of any one of the preceding claims, the apparatus recording patient eye and / or pupil data by operation of the at least one activation means, and the apparatus automatically sending the recorded data to a remote location for subsequent analysis.

39. A method of obtaining a recording of a patient’s eye motion for use in assessing health condition of the patient, the method including: patient self-initiated operation of the apparatus of any one of the preceding claims, the apparatus recording patient eye and / or pupil movement by operation of at least one activation means, and the apparatus automatically sending the recorded data to a remote location for subsequent analysis.

40. The method of claim 38 or 39, wherein operation of the at least one activation means includes use of a single input device of the apparatus or automatic operation of the input device when the patient puts the apparatus to their face.

41. The method of claim 38, 39 or 40, wherein the apparatus is configured to record a session, ensure calibration and / or configuration and alignment with the patient’s eyes / pupils during recording, and send the recorded data to a remote location or cloud storage for subsequent review, without requiring the user’s / patient’s functional input to the apparatus beyond the patient’s operation of the at least one activation means of the apparatus.

42. The method of claim 41, wherein the apparatus calibration and / or configuration includes at least one of: frame positioning or windowing, apparatus positioning and / or gaze positioning / pupil position.

43. The method of claim 41 or 42, wherein the calibration and / or configuration includes one or more of: adjusting / compensating for angle of gaze, adjusting / compensating for focus and / or adjusting / compensating for illumination.

44. The method of any one of claims 41 to 43, wherein the apparatus self-calibrates and / or configures and assesses alignment with the patient’s eyes / pupils.

45. The method of any one of claims 38 to 44, wherein the apparatus ceases recording if sufficient external light is detected entering into a space within the apparatus between at least one image capture means and the patient’s pupils.

46. The method of any one of claims 38 to 45, wherein the apparatus ceases recording if the apparatus is unable to detect at least one said pupil of the patient for a period of time.

47. The method of any one of claims 38 to 46, wherein the apparatus automatically transmits the recorded eye / pupil movement data remotely either during the recording or after the recording, or a combination of both.

48. The method of any one of claims 38 to 47, wherein the apparatus is configured to conclude recording when the patient again operates the input device.

49. The method of any one of claims 38 to 48, wherein the apparatus is calibrated and / or configured to the user / patient for self-use by the user / patient.

50. The method of any one of claims 38 to 48 wherein at least one frame pulse is provided during recording such that an accelerometer records accelerometer data insynchronisation (in-sync) with the eye / pupil movement image recording.

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