Swallowing measurement

Abstract

1. A diagnostic device configured to count a number of swallows of a user, the diagnostic device comprising: at least one processor; a user interface; one or more sensors associated with the device; and a memory storing computer-readable instructions that, when executed by the at least one processor, cause the diagnostic device to: prompt a user via the user interface to provide a user input via one or more sensors associated with the device each time the user reaches a predetermined time point during a swallowing act; receive a plurality of inputs via the one or more sensors, each user input corresponding to a respective time that the user is at the predetermined time point during the swallowing act; generate a timestamp associated with each user input in response to receiving each user input; apply a counting model to data including the plurality of generated timestamps, the counting model being configured to calculate a number of swallows of the user by counting a total number of timestamps in the data including the plurality of generated timestamps; and output the calculated number of swallows.

Description

[Technical Field]

[0001] The present invention relates to a diagnostic device and computer-implemented method for determining how many swallows a subject has had. [Background technology]

[0002] Spinal muscular atrophy (SMA) is associated with bulbar palsy. Patients with SMA (PlwSMA) often suffer from difficulty swallowing (dysphagia). Dysphagia ranges from minor problems swallowing certain types of food or liquids (e.g., very hard or dry foods, very thin liquids) to requiring more swallowing for food boluses, to complete dependence on tube feeding and complete inability to swallow {van der Heul et al. 2019, PMID 31476167}. However, tube feeding does not completely eliminate swallowing. Many tube-fed patients regularly consume food orally for recreational purposes and still need to deal with saliva (approximately 1 liter or 300 swallows per day).

[0003] Although dysphagia is thought to progress slowly, it is not uncommon for severe deterioration to be reported to clinicians as sudden, perhaps as a result of a lack of coping strategies and tools to track progression over time. Individuals with PlwSMA who have dysphagia may have difficulty obtaining enough nutrients to maintain weight and are at risk for subclinical laryngeal invasion and aspiration, where food or liquid enters the airway. Laryngeal invasion and aspiration, particularly when combined with subclinical (unawareness of the individual) or weak cough (inadequate airway clearance), can lead to life-threatening respiratory tract infections. {McGrattan et al. 2021, PMID 33822657}

[0004] Individuals with PlwSMA who report swallowing problems may undergo videofluoroscopic swallowing studies (VFSS) or, in an effort to limit radiation exposure, fiberoptic endoscopic evaluation of their swallowing. {Audag et al. 2019, PMID 30728931; Nacci et al. 2008, PMID 18939710}. The primary purpose of VFSS is to derive safe food and beverage recommendations for individuals, particularly by using global clinical scales such as the "Laryngeal Intrusion and Aspiration Scale" or the "Swallowing Outcome Severity Scale" to grade the severity of observed laryngeal intrusion and / or aspiration. {Rosenbek et al. 1996, PMID 8721066; O'Neil et al. 1999, PMID 10341109}. These recommendations often involve avoiding dry, hard foods and / or thin liquids (which is why swallowing saliva poses a significant risk). However, the output of the VFSS is subjective and dependent on the examiner's experience, as outlined in Katlyn McGrattan's article. Despite the prevalence of dysphagia in PlwSMA, it is noteworthy that in clinical practice, VFSS is rare and performed only with serious suspicion (e.g., when severe swallowing problems have already been reported). The VFSS is not a tool for tracking dysphagia over time. Other patient-reported outcomes, such as the Neuromuscular Disease Dysphagia Scale or the Sydney Swallowing Questionnaire, exist but are rarely used systematically in PlwSMA {Audag et al. 2019, PMID 30728931}.

[0005] It is therefore desirable to provide a method for collecting swallowing data from patients that does not suffer from the problems outlined above. Summary of the Invention

[0006] At a high level, the present invention provides an apparatus and computer-implemented method for determining the number of swallows a subject has taken, for example, within a given period of time. More specifically, a user is prompted to provide input to the apparatus each time a predetermined point in the swallowing cycle is reached. From the series of inputs, the apparatus can then calculate the number of swallows the user has taken.

[0007] Accordingly, a first aspect of the present invention provides a diagnostic device configured to measure the number of swallows by a subject, the device comprising at least one processor, one or more sensors associated with the device, a user interface, and a memory storing computer-readable instructions that, when executed by the at least one processor, cause the diagnostic device to: prompt a user via the user interface to provide a user input via one or more sensors associated with the device each time the user reaches a predetermined time point during a swallowing act; receive a plurality of user inputs via the one or more sensors, each user input corresponding to a respective time that the user is at a predetermined time point during the swallowing act; generate a timestamp associated with each user input in response to receiving each user input; apply a counting model to data including the plurality of generated timestamps, the counting model being configured to calculate the number of swallows for the subject by counting the total number of timestamps in the data including the plurality of generated timestamps; and output the calculated number of swallows.

[0008] The combination of prompting the user, receiving a plurality of user inputs, generating a timestamp, applying the count model, and outputting the calculated number of swallows may correspond to performing a “swallowing test.” That is, the computer-readable instructions, when executed by the at least one processor, may cause the device to perform a swallowing test, which may include the steps described above.

[0009] For example, it is known that the number of swallows in a given amount of time can be correlated with validated clinical tools for assessing dysphagia, such as the EAT-10 (Eating Assessment Tool-10) or the SSQ (Sydney Swallowing Questionnaire), both of which may be useful in conducting clinical evaluations. Measuring swallow volume using a diagnostic device according to the first aspect of the present invention may enable effective tracking of the progression of various muscle disorders, such as SMA, in a subject through active testing of the subject. Use of a diagnostic device according to the first aspect of the present invention may be particularly effective in assessing, for example, the severity of symptoms (i.e., dysphagia) and the progression of bulbar muscle disorders, such as SMA, through active testing of the subject. As described in more detail later in this application, a diagnostic device according to the first aspect of the present invention may use the calculated number of swallows to indicate and / or track the presence or progression of a muscle disorder, such as SMA, in a subject or user.

[0010]

[0004] Embodiments of the diagnostic device may be used to evaluate the swallowing of food and / or beverages. Thus, the computer-readable instructions, when executed by the device, may further cause the diagnostic device to prompt the user, via a user interface, to consume food. Alternatively or additionally, the computer-readable instructions may further cause the diagnostic device to prompt the user, via a user interface, to consume a beverage. The predetermined point during the swallowing act may be the beginning or end of the swallowing act. This may allow for more reliable swallow counts because the point at which the user begins or ends the swallowing act may be more easily identified.

[0011] The computer-readable instructions, when executed by the device, may further cause the diagnostic device to prompt the user, via the user interface, to take a single chew from the food or take a sip from the beverage. The computer-readable instructions, when executed by the device, may further cause the diagnostic device to prompt the user, via the user interface, to swallow the food or beverage a number of times necessary to clear the mouth. Thus, the user may be prompted to take a single chew from the food or take a sip from the beverage and to provide user input after each swallow for the number of swallows it takes to clear the mouth. The computer-readable instructions, when executed by the device, may cause the diagnostic device to receive the required number of user inputs and / or receive user input for the required period of time corresponding to the number of swallows required for the user to clear the mouth. There may be no limit on the number of inputs that may be received or the period of time that the user input may be received.

[0012] The computer-readable instructions, when executed by at least one processor, may cause the diagnostic device to perform multiple swallowing tests. In each swallowing test, the user may be prompted to consume a food or beverage, or to chew a food once or take a sip of a beverage. Among the multiple swallowing tests, there may be at least one swallowing test in which the user is prompted to consume a food or chew a food once (a "food swallowing test"), and at least one swallowing test in which the user is prompted to drink a beverage or take a sip (a "beverage swallowing test"). Among the multiple swallowing tests, there may be more than one food swallowing test, for example, at least three. Among the multiple swallowing tests, there may be more than one beverage swallowing test, for example, at least three. When executed by the at least one processor, the computer-readable instructions may cause the diagnostic device to prompt the user to consume one or more sips of a beverage between each food swallowing test. The computer readable instructions, when executed by at least one processor, may perform one or more food swallowing tests and one or more drink swallowing tests in alternating order.

[0013] The food or drink may be a specified food or drink, such as a banana or water. The computer-readable instructions, when executed by the at least one processor, may cause the diagnostic device to display an indication of the specified food or drink via a user interface. For example, the specified food or drink may be displayed as a graphic.

[0014] In a preferred embodiment, the device is or includes a smartphone. This is advantageous because smartphones are virtually everyone's today. By performing a computer-implemented process as described on the smartphone, the user does not need to go to, for example, a hospital or other clinical site to measure the number of swallows. Other types of diagnostic devices may be used, such as tablets, laptop computers, desktop computers, etc. Alternatively, the diagnostic device may be a dedicated swallowing measurement device.

[0015] The diagnostic device preferably further comprises a display component configured to display a user interface. Preferably, the display component is in the form of a screen, such as a touchscreen. In embodiments in which the display component comprises a touchscreen, the touchscreen preferably includes one or more sensors associated with the device. In these cases, the sensors may include resistive sensors, capacitive sensors, surface acoustic wave sensors, infrared grid sensors, infrared acrylic projection sensors, optical imaging sensors, piezoelectric sensors, and / or acoustic pulse recognition sensors. In most cases, the one or more sensors are capacitive sensors, as these are most commonly used in smartphones. Capacitive sensors function on the basis that when a person touches the screen, its electrostatic field is distorted and a change in capacitance is recorded.

[0016] The counting model may be configured to count the number of swallows a subject takes within a predetermined time range or duration. In some cases, rather than or in addition to counting the number of raw swallows, the diagnostic model may be configured to determine, derive, or measure a swallowing rate. In such cases, the computer-readable instructions, when executed by at least one processor, may be configured to cause the diagnostic device to apply the swallowing rate model (similar to or in addition to the counting model) to data including a plurality of timestamps to calculate the swallowing rate. The swallowing rate model may be further configured to calculate a time difference between two timestamps of the plurality of timestamps and calculate the swallowing rate based on the inverse of the calculated time difference. In some cases, the earlier of the two timestamps may immediately precede the later of the two timestamps. In other words, the two timestamps may be consecutive timestamps. Alternatively, there may be n timestamps between the earlier of the two timestamps and the later of the two timestamps, and the swallowing rate model is configured to calculate the swallowing rate by multiplying the inverse of the time difference by (n+1). By inverting the time difference as outlined above, the swallowing rate model can calculate the swallowing rate in swallows per second. In some cases, the swallowing rate model may be further configured to multiply the inverted time difference (i.e., the inverse) by 60 to obtain the swallowing rate in swallows per minute. Note that the time difference between two consecutive timestamps may correspond to the swallowing duration. In some examples, the swallowing rate model may be configured to calculate the average swallowing duration by summing multiple time differences, where each time difference is the difference between two consecutive timestamps, and dividing the sum by n, where n is the number of time differences. The swallowing rate model may then calculate the average swallowing rate by taking the inverse of the average swallowing duration.

[0017] We now discuss how the calculated swallow count may be used to indicate the presence or progression of a muscle disorder, such as SMA. The computer-readable instructions, when executed by at least one processor, may cause the diagnostic device to apply a clinical interpretation model to the calculated swallow count. The clinical interpretation model may output an indication of the presence or absence of a muscle disorder, such as SMA, in the user, or an indication of the progression of the muscle disorder in the user. The clinical interpretation model may be configured to compare the calculated swallow count to a predetermined value and, based on the comparison, output an indication of the presence or absence of a muscle disorder, such as SMA. In particular, the clinical interpretation model may be configured to determine whether the calculated swallow count is greater than a predetermined threshold, and, if the calculated swallow count is determined to be greater than the predetermined threshold, output an indication of the presence of a muscle disorder (e.g., that the user has PlwSMA), and / or output an indication of the absence of a muscle disorder if the calculated swallow count is determined to be equal to or less than the predetermined threshold. The predetermined threshold may be equal to or less than 2, for example, the predetermined threshold may be 1.

[0018] In some examples, applying the clinical interpretation model may include applying the clinical interpretation model to a plurality of calculated swallow counts, where each calculated swallow count is calculated in a different swallowing test. The clinical interpretation model may be configured to determine a minimum number of swallows among the plurality of calculated swallow counts. The minimum number of swallows may refer to the fewest number of swallows. In some examples, each of the calculated swallow counts may be calculated in a different food swallowing test. In some examples, each of the calculated swallow counts may be calculated in a different food swallowing test in which the user is prompted to chew food once.

[0019] The clinical interpretation model may be configured to compare the minimum number of swallows with a predetermined value and, based on the comparison, output an indication of the presence or absence of a muscle disorder, such as SMA. In particular, the clinical interpretation model may be configured to determine whether the minimum number of swallows is greater than a predetermined threshold, and output an indication of the presence of a muscle disorder (e.g., that the user has PlwSMA) if the minimum number of swallows is determined to be greater than the predetermined threshold, and / or output an indication of the absence of a muscle disorder if the minimum number of swallows is determined to be equal to or less than the predetermined threshold. The predetermined threshold may be equal to or less than 2, e.g., the predetermined threshold may be 1. A PlwSMA individual may never or very unlikely be able to clear their mouth after only one swallow and one chew. A healthy individual may always or very likely be able to clear their mouth after only one swallow and one chew at least once in a series of tests. A second aspect of the present invention provides a computer-implemented method for measuring the number of swallows performed by a subject. The computer-implemented method includes the steps of prompting a user via a user interface to provide user input via one or more sensors associated with the device each time the user reaches a predetermined time point during the swallowing act; receiving a plurality of inputs via the one or more sensors, each user input corresponding to a respective time the user is at a predetermined time point during the swallowing act; generating a timestamp associated with each user input in response to receiving each user input; applying a count model to data including the plurality of generated timestamps, the count model being configured to calculate the number of swallows for the subject by counting the total number of timestamps in the data including the plurality of generated timestamps; and outputting the calculated number of swallows.

[0020] In preferred cases, the computer-implemented method of the second aspect of the invention is executed by a processor of a diagnostic device, such as the diagnostic device of the first aspect of the invention. It will be understood that any feature described above with respect to the first aspect of the invention applies equally well to the second aspect of the invention, unless the context clearly dictates otherwise or unless combinations of such features are clearly technically incompatible.

[0021] A third aspect of the present invention provides a computer program comprising instructions which, when executed by a processor of a computer (or other suitable data processing device), cause the processor to perform the computer-implemented method of the second aspect of the invention. A further aspect of the present invention provides a computer-readable storage medium having stored thereon the computer program of the third aspect of the invention.

[0022] The present invention includes combinations of the described embodiments and preferred features except where such combinations are expressly not permitted or explicitly avoided. [Brief explanation of the drawings]

[0023] Embodiments of the present invention will now be described with reference to the accompanying drawings. [Figure 1] FIG. 1 is a diagram showing an example of an environment in which a diagnostic device for evaluating the number of swallows performed by a subject is installed. [Figure 2] 1 is a flow diagram of a computer-implemented method for assessing the number of times a user swallows. [Figure 3] 1 is a flow diagram of a computer-implemented method for determining an indication of the presence or absence of a muscle disorder such as SMA. [Figure 4] Plot showing the number of swallows calculated for PlwSMA and healthy individuals. [Figure 5] FIG. 1 illustrates an example of a network architecture and data processing device that can be used to implement one or more exemplary aspects described herein. DETAILED DESCRIPTION OF THE INVENTION

[0024] Aspects and embodiments of the present invention will now be described with reference to the accompanying figures. Further aspects and embodiments will be apparent to those skilled in the art. All documents mentioned herein are incorporated by reference.

[0025] In the following description of various aspects, reference is made to the accompanying drawings, which form a part hereof, and which show, by way of illustration, various embodiments in which the aspects described herein may be practiced. It is to be understood that other aspects and / or embodiments may be utilized and structural and functional changes may be made without departing from the scope of the described aspects and embodiments.

[0026] The aspects described herein are capable of other embodiments and of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. Rather, the phrases and terms used herein should be given their broadest interpretation and meaning. The use of "including" and "comprising" and variations thereof is intended to encompass the items listed thereafter and their equivalents, as well as additional items and their equivalents. The use of the terms "mounted," "connected," "coupled," "disposed," "engaged," and similar terms is meant to include both direct and indirect mounting, connecting, coupling, disposing, and engaging.

[0027] The systems, methods, and devices described herein provide diagnostic devices and computer-implemented methods for assessing, measuring, or determining the number of swallows performed by a patient, e.g., a patient suffering from a bulbar muscle disorder such as certain SMA. In some cases, the diagnostic device may be in the form of a mobile device, particularly a smartphone, with a specific software application installed. The software application may be configured to execute (or cause a processor of the mobile device to execute) a corresponding computer-implemented method.

[0028] In some cases, the diagnosis acquires or receives sensor data from one or more sensors associated with the mobile device when the subject uses the mobile device to interact with the software application. In some cases, the sensors may be located within the mobile device. In some cases, the patient's swallowing frequency is derived, calculated, or extracted from the received or acquired sensor data. In some cases, an assessment of the severity and progression of symptoms of muscle disorders, particularly SMA, in the subject may be determined based on the extracted sensor features.

[0029] In embodiments of the present invention, the diagnostic device may prompt the subject to perform a diagnostic task. In some cases, the diagnostic task is anchored or modeled after established methods and standardized tests. In some cases, in response to the subject performing the diagnostic task, the diagnostic device acquires or receives sensor data via one or more sensors. In some cases, the sensors may be in a mobile device or in a wearable sensor worn by the subject. In some cases, sensor features associated with symptoms of myopathy, particularly SMA, are extracted from the received or acquired sensor data. In some cases, an assessment of the severity and progression of symptoms of myopathy, particularly SMA, in the subject is determined based on the extracted features of the sensor data.

[0030] Assessment of the severity and progression of symptoms of myopathies, particularly SMA, using a diagnostic according to the present disclosure correlates well with assessments based on clinical outcomes and can therefore replace clinical subject monitoring and testing. Exemplary diagnostics according to the present disclosure can be used outside of a clinic environment, thus offering advantages in cost, ease of subject monitoring, and convenience for the subject. This facilitates frequent subject monitoring and testing, particularly daily, resulting in a better understanding of disease stages and providing disease-related insights useful to both the clinical and research communities. Exemplary diagnostics according to the present disclosure can provide earlier detection of even minor changes in swallowing function, which can indicate the presence or progression of myopathies, particularly SMA, in a subject, and can therefore be used for better disease management, including personalized treatment.

[0031] FIG. 1 is a diagram of an exemplary environment in which a diagnostic device 105 is provided for assessing the number of swallows performed by a subject 110, e.g., with a muscle disorder, particularly SMA. In some cases, the device 105 may be a smartphone, smartwatch, or other mobile computing device. The device 105 includes a display screen 160. In some cases, the display screen 160 may be a touchscreen. The device 105 includes at least one processor 115 and a memory 125 storing computer instructions for a symptom monitoring application 130 that, when executed by the at least one processor 115, causes the device 105 to assess one or more swallows performed by the subject 110, e.g., a patient with a muscle disorder, particularly SMA, and / or determine an indication of the presence or absence of a muscle disorder, such as SMA. The device 105 receives a plurality of sensor data via one or more sensors associated with the device 105. In some cases, the one or more sensors associated with the device are at least one of sensors disposed within the device and sensors worn by the subject and configured to communicate with the device. In FIG. 1, the sensors associated with the device 105 include a first sensor 120 a disposed within a display screen 160 of the device 105 .

[0032] The device 105 extracts the number of swallows performed by the subject 110 from the received first sensor data.

[0033] The device 105 determines the number of swallows performed by the subject 110 based on the extracted features. Optionally, the device 105 transmits the extracted features to the server 150 over the network 180. Optionally, the device 105 transmits the first sensor data to the server 150 over the network 180. The server 150 includes at least one processor 155 and a memory 161 that stores computer instructions for a symptom assessment application 170, the computer instructions, when executed by the server processor 155, causing the processor 155 to determine the number of swallows performed by the subject 110 based on the extracted features received by the server 150 from the device 105. Optionally, the symptom assessment application 170 may determine the number of swallows performed by the subject 110 based on the extracted features of the sensor data received from the device 105 and a subject database 175 stored in the memory 160. Multiple swallowing tests may be performed, with first sensor data collected and processed for each test, resulting in a determination of multiple swallow counts. The symptom assessment application 170 may further determine an indication of the presence or absence of a muscle disorder, such as SMA, from the determined swallow count(s), and may output the indication. In some cases, the subject database 175 may include subject data and / or clinical data. In some cases, the subject database 175 may include in-clinic and sensor-based measures of the number of swallows the subject 110 has taken. In some cases, the subject database 175 may be independent of the server 150. In some cases, the server 150 transmits the determined swallow count(s) and / or an indication of the presence or absence of a muscle disorder to the device 105. In some cases, the device 105 may output the swallow count. In some cases, the device 105 may communicate information to the subject 110 based on the evaluation. In some cases, the swallow count evaluation or an indication of the presence or absence of a muscle disorder may be communicated to a clinician, who may determine an individualized treatment for the subject 110 based on the evaluation.

[0034] In some cases, the computer instructions of the symptom monitoring application 130, when executed by the at least one processor 115, cause the device 105 to determine the number of swallows performed by the subject 110 based on the subject's 110 active testing. The device 105 prompts the subject 110 to perform one or more tasks. The number of swallows may be calculated for each task. In some cases, prompting the subject 110 to perform the one or more diagnostic tasks includes prompting the subject 110 to eat or chew a food, or consume or take a sip of a beverage, and tap a touchscreen (or equivalent sensor) at the beginning and / or end of each swallow. The prompts may further specify the food or beverage to be eaten / drinked.

[0035] In response to the subject 110 performing each of the one or more diagnostic tasks, the diagnostic device 105 receives a plurality of sensor data via one or more sensors associated with the device 105, the sensor data including a series of timestamps corresponding to times indicating (via the sensors) when the user swallowed. The device 105 extracts from the received sensor data for each diagnostic task, for example, the number of times the user swallowed within a particular time frame. Thus, the number of swallows may be determined. Symptoms of muscle disorders in the subject 110, particularly SMA, may include symptoms that affect the swallowing function of the subject 110.

[0036] Thus, the device may further determine the presence or absence of a muscle disorder such as SMA from one or more swallow counts, for example, by determining the smallest or lowest swallow count among the plurality of swallow counts.

[0037] Figure 2 illustrates an exemplary method for assessing the number of user swallows in a subject based on active testing of the subject using the exemplary device 105 of Figure 1. While Figure 2 is described with reference to Figure 1, it should be noted that the steps of the method of Figure 2 may be performed by other systems. The computer-implemented method includes, at step 205, prompting the subject to provide user input on a user input interface displayed on the display 160 of the device 105 each time the subject reaches a predetermined point in the swallowing process (e.g., the beginning). The method includes receiving a plurality of sensor data (step 210) via one or more sensors, which may be in the form of capacitance sensors in a touchscreen of the display component 160, in response to the subject performing one or more tasks.

[0038] A counting model is then applied to the data containing the multiple timestamps in step 215. The features of the counting model are described in detail elsewhere in this patent application and will not be repeated here for the sake of brevity.

[0039] In step 220, the number of swallows is output, for example by processor 107 generating instructions that, when executed by display component 160 of device 105, cause display component 160 to display the number of swallows. Alternatively, the calculated number of swallows may be transmitted to server 150, as outlined elsewhere herein.

[0040] As explained above, assessment of the severity and progression of symptoms of muscle disorders, particularly SMA, using diagnostics according to the present disclosure correlates well with clinical outcome-based assessments and may therefore replace clinical subject monitoring and testing.

[0041] FIG. 3 illustrates an exemplary method for determining an indication of the presence or absence of SMA in a subject based on the subject's active testing using the exemplary device 105 of FIG. 1. While FIG. 3 is described with reference to FIG. 1, it should be noted that the steps of the method of FIG. 3 may be performed by other systems. The computer-implemented method includes, in step 225, calculating a number of swallows, where the number of swallows for each swallow is determined according to the method described with reference to FIG. 2. That is, the number of swallows for each swallow may be calculated in a separate swallowing test. The multiple swallowing tests may include only a swallowing test in which the user is prompted to chew food once, or may include at least three food swallowing tests. Between each of these swallowing tests, the user may be prompted to take a sip of a beverage. In step 230, the computer-implemented method includes determining a minimum number of swallows among the multiple swallows. Next, in step 240, the computer-implemented method includes determining whether the determined minimum number of swallows is greater than a predetermined threshold. If the calculated number of swallows is determined to be greater than the predetermined threshold, the computer-implemented method includes outputting an indication of the presence of an SMA at step 245. If the calculated number of swallows is determined to be less than or equal to the predetermined threshold, the computer-implemented method includes outputting an indication of the absence of an SMA at step 250.

[0042] The predetermined threshold may be 2 or less, for example, the predetermined threshold may be 1. That is, a minimum number of swallows greater than 1 may indicate that the user has PlwSMA, and a minimum number of swallows less than or equal to 1 may indicate that the user does not have PlwSMA. This may be explained with reference to FIG. 4, which is a plot showing the minimum number of swallows determined for PlwSMA and healthy individuals. The plot shows that all of the PlwSMA individuals have a minimum number of swallows test result greater than 1, while all of the healthy individuals have a minimum number of swallows test result less than or equal to 1.

[0043] FIG. 5 illustrates an example of a network architecture and data processing apparatus that may be used to implement one or more exemplary embodiments described herein, such as those described in FIGS. 1 and 2. Various network nodes 303, 305, 307, and 309 may be interconnected via a wide area network (WAN) 301, such as the Internet. Other networks, including private intranets, corporate networks, LANs, wireless networks, and personal networks (PANs), may also or instead be used. Network 301 is illustrative and may be replaced by fewer or additional computer networks. The local area network (LAN) may have one or more of any known LAN topologies and may use one or more of a variety of protocols, such as Ethernet. Devices 303, 305, 307, 309 and other devices (not shown) may be connected to one or more of the networks via twisted pair wire, coaxial cable, optical fiber, radio waves, or other communication media.

[0044] As used herein and shown in the drawings, the term "network" refers not only to a system in which remote storage devices are coupled together through one or more communication paths, but also to stand-alone devices that may be coupled to such a system from time to time with storage capabilities. Thus, the term "network" includes not only a "physical network" but also a "content network" consisting of data—belonging to a single entity—that resides across all physical networks.

[0045] The components may include a data server 303, a web server 305, and client computers 307, 309. The data server 303 provides overall access, control, and management of the databases and control software for implementing one or more exemplary embodiments described herein. The data server 303 may be connected to a web server 305 with which users interact and obtain requested data. Alternatively, the data server 303 may itself operate as a web server and be connected directly to the Internet. The data server 303 may be connected to the web server 305 via a network 301 (e.g., the Internet) through a direct or indirect connection, or through some other network. Users may interact with the data server 303 using remote computers 307, 309, for example, by using a web browser to connect to the data server 303 through one or more publicly accessible websites hosted by the web server 305. The client computers 307, 309 may be used in conjunction with the data server 303 to access data stored in the data server 303, or may be used for other purposes. For example, from client device 307, a user may access web server 305 using an internet browser as known in the art or by executing a software application that communicates with web server 305 and / or data server 303 over a computer network (such as the internet). In some cases, client computer 307 may be a smartphone, smartwatch, or other mobile computing device and may implement a diagnostic device such as device 105 shown in FIG. 1. In some cases, data server 303 may implement a server such as server 150 shown in FIG. 1.

[0046] The servers and applications may be combined on the same physical device, maintain separate virtual or logical addresses, or may reside on separate physical devices. Figure 1 shows only one example of a network architecture that may be used, and those skilled in the art will appreciate that the specific network architecture and data processing devices used may vary and are secondary to the functions they provide, as described further herein. For example, the services provided by web server 305 and data server 303 may be combined on a single server.

[0047] Each of the components 303, 305, 307, and 309 may be any type of known computer, server, or data processing device. The data server 303 may include, for example, a processor 311 that controls the overall operation of the rate server 303. The data server 303 may further include RAM 313, ROM 315, a network interface 317, an input / output interface 319 (e.g., a keyboard, a mouse, a display, a printer, etc.), and memory 321. The I / O 319 may include various interface units and drivers for reading, writing, displaying, and / or printing data or files. The memory 321 may further store operating system software 323 for controlling the overall operation of the data processing device 303, control logic 325 for directing the data server 303 to perform aspects described herein, and other application software 327 that provides secondary support and / or other functions that may or may not be used in combination with other aspects described herein. The control logic is sometimes referred to herein as data server software 325. The functionality of the data server software may refer to actions or decisions that are made automatically based on rules coded into the control logic, actions or decisions that are made manually by a user by providing input to the system, and / or a combination of automated processing based on user input (e.g., queries, data updates, etc.).

[0048] Additionally, memory 321 may store data used to perform one or more aspects described herein, including first database 329 and second database 331. In some cases, the first database may include a second database (e.g., as another table, report, etc.). That is, information may be stored in a single database or, alternatively, separated into different logical, virtual, or physical databases, depending on the system design. Devices 305, 307, and 309 may have architectures similar to or different from that described with respect to device 303. Those skilled in the art will understand that the functionality of data processing device 303 (or devices 305, 307, and 309) described herein may be distributed across multiple data processing devices, for example, to distribute processing load across multiple computers, to segregate transactions based on geographic location, user access level, quality of service (QoS), etc.

[0049] One or more aspects described herein may be embodied in computer-usable or readable data and / or computer-executable instructions, such as in one or more program modules executed by one or more computers or other devices described herein. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types when executed by a processor in a computer or other device. Modules may be written in source code programming languages ​​that are subsequently compiled for execution, or in scripting languages ​​such as, but not limited to, HTML or XML. Computer-executable instructions may be stored in computer-readable media such as hard disks, optical disks, removable storage media, solid-state memory, RAM, etc. As will be appreciated by those skilled in the art, the functionality of the program modules may be combined or distributed as desired in various embodiments. Furthermore, the functionality may be embodied, in whole or in part, in firmware or hardware equivalents, such as integrated circuits, field-programmable gate arrays (FPGAs), etc. Particular data structures may be used to more effectively implement one or more aspects, and such data structures are contemplated within the scope of the computer-executable instructions and computer-usable data described herein.

[0050] The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, and expressed in a specific form or in terms of means for performing a disclosed function or a method or process for obtaining a disclosed result, may be utilized, individually or in any combination of such features, as appropriate, to realize the invention in its various forms.

[0051] While the present invention has been described in conjunction with the foregoing exemplary embodiments, many equivalent modifications and variations will be apparent to those skilled in the art given this disclosure. Accordingly, the exemplary embodiments of the invention described above are considered to be illustrative and not limiting. Various changes may be made to the described embodiments without departing from the spirit and scope of the invention.

[0052] For the avoidance of doubt, any theoretical explanations provided herein are provided for the purpose of enhancing the understanding of the reader, and the inventors do not wish to be bound by any of these theoretical explanations.

[0053] Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0054] Throughout this specification, including the claims which follow, unless the context requires otherwise, the words "comprise" and "include", as well as variations such as "comprises", "comprising", and "including", are understood to mean the inclusion of a stated integer or step or steps, but not the exclusion of any other integer or step or steps.

[0055] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" one particular value and / or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. The term "about" with respect to numerical values ​​is arbitrary and means, for example, + / - 10%.

Claims

1. 1. A diagnostic device configured to count the number of swallows of a user, comprising: at least one processor; A user interface; one or more sensors associated with the device; and a memory storing computer readable instructions that, when executed by the at least one processor, cause the diagnostic device to perform a swallowing test, the swallowing test including: prompting the user via the user interface to provide user input via the one or more sensors associated with the device each time the user reaches a predetermined point during a swallowing act; receiving a plurality of inputs via the one or more sensors, each user input corresponding to a respective time at which the user is at a predetermined point during the swallowing act; responsive to receiving each user input, generating a timestamp associated with each said user input; applying a counting model to data comprising a plurality of the generated timestamps, the counting model being configured to calculate a number of swallows for the user by counting a total number of the timestamps in the data comprising the plurality of generated timestamps; outputting the calculated number of swallowings; A diagnostic device that performs the following.

2. The diagnostic device of claim 1 , comprising a smartphone having a display component configured to display the user interface.

3. The diagnostic device of claim 2 , wherein the display component includes a touchscreen with the one or more sensors, and the user input is a screen touch detectable by the one or more sensors.

4. The diagnostic device of claim 3 , wherein the one or more sensors include a capacitance sensor.

5. 5. The diagnostic device of claim 1, wherein the computer-readable instructions, when executed by the at least one processor, further cause the diagnostic device to prompt the user via the user interface to consume food.

6. 6. The diagnostic device of claim 1, wherein the computer-readable instructions, when executed by the at least one processor, further cause the diagnostic device to prompt the user via the user interface to consume a beverage.

7. The diagnostic device according to any one of claims 1 to 6, wherein the predetermined time point during the swallowing action is the start or end of the swallowing action.

8. The diagnostic device of any one of claims 1 to 7, wherein the computer readable instructions, when executed by the at least one processor, cause the diagnostic device to perform a plurality of swallowing tests.

9. 9. The diagnostic device of claim 8, wherein the computer-readable instructions, when executed by the at least one processor, cause the diagnostic device to apply a clinical interpretation model to a plurality of the calculated swallow counts, the clinical interpretation model outputting an indication of the presence or absence of a muscle disorder.

10. The diagnostic device of claim 9 , wherein the clinical interpretation model is configured to determine a minimum number of swallows from the plurality of calculated swallow counts.

11. 11. The diagnostic apparatus of claim 10, wherein the clinical interpretation model is configured to compare the minimum number of swallows to a predetermined value and to output the indication of the presence or absence of the muscle disorder based on the comparison.

12. 12. The diagnostic device of claim 11, wherein the clinical interpretation model is configured to determine whether the minimum number of swallows is greater than a predetermined threshold, and to output an indication of the presence of the myopathy if it is determined that the minimum number of swallows is greater than the predetermined threshold, and to output an indication of the absence of the myopathy if it is determined that the minimum number of swallows is equal to or less than the predetermined threshold.

13. The diagnostic device of claim 12 , wherein the predetermined threshold is 1.

14. 1. A computer-implemented method for counting swallows in a subject, comprising: prompting the subject via a user interface to provide user input via one or more sensors associated with a diagnostic device each time the user reaches a predetermined point during a swallowing event; receiving a plurality of inputs via the one or more sensors, each user input corresponding to a respective time at which the user is at a predetermined point during the swallowing act; responsive to receiving each user input, generating a timestamp associated with each said user input; applying a count model to data comprising a plurality of the generated timestamps, the count model being configured to calculate a number of swallows of the user by counting a total number of the timestamps in the data comprising the plurality of generated timestamps; 11. A computer-implemented method comprising:

15. 15. The computer-implemented method of claim 14, further comprising applying a clinical interpretation model to the calculated number of swallows, the clinical interpretation model outputting an indication of the presence or absence of a muscle disorder or an indication of the progression of a muscle disorder.

16. A computer-implemented method according to claim 14 or 15, executed by a processor of a diagnostic device according to any one of claims 1 to 13.

17. the steps of prompting the subject, receiving the user input, and generating the timestamp are performed by a processor of a diagnostic device, and the step of applying the count model is performed by a processor of a server, and the diagnostic device is configured to transmit the generated timestamp to the server, and the diagnostic device: at least one processor; A user interface; one or more sensors associated with the device; and a memory storing computer readable instructions that, when executed by the at least one processor, cause the diagnostic device to perform a swallowing test, the swallowing test including: prompting the user via the user interface to provide user input via the one or more sensors associated with the device each time the user reaches a predetermined point during a swallowing act; receiving a plurality of user inputs via the one or more sensors, each user input corresponding to a respective time at which the user is at a predetermined point during a swallowing act; in response to receiving each user input, generating a timestamp associated with each said user input; 16. The computer-implemented method of claim 14 or 15,

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