Swallowing measurement

Abstract

There is provided a diagnostic device configured to count a number of swallowing times of a user, the 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 perform a swallowing action when the user is at a predetermined point during the swallowing action. Prompting, via the user interface, the user to provide user input via the one or more sensors associated with the device; 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 action; in response to receiving each user input, generating a timestamp associated with the respective user input; applying a counting model to data including a plurality of generated timestamps, wherein the counting model is configured to calculate a number of swallowing times of the user by counting a total number of timestamps in the data including the plurality of generated timestamps; and outputting the calculated number of times of swallowing.

Description

Technical Field

[0001] The present invention relates to a diagnostic device and a computer-implemented method for determining the number of times a subject has swallowed. Background Art

[0002] Spinal muscular atrophy (SMA) is associated with bulbar weakness. People with SMA (PlwSMA) are often affected by difficulty swallowing (dysphagia). The degree of dysphagia ranges from minor problems swallowing certain types of food or liquids (e.g., very hard or dry foods, very thin liquids), to the need for multiple swallows for boluses, to complete inability to swallow and complete reliance on tube feeding {van der Heul et al., 2019, PMID 31476167}. However, tube feeding does not completely eliminate swallowing; many tube-fed patients regularly ingest orally for pleasure, and they still need to process their saliva (approximately 1 liter or 300 swallows per day).

[0003] Although the progression of dysphagia is considered slow, it is not uncommon for sudden severe deterioration to be reported to clinicians, which may be due to coping strategies and the lack of tools to track longitudinal progression. PlwSMA with dysphagia may have difficulty obtaining adequate nutrition to maintain their weight, and they are at risk for (silent) penetration and aspiration, in which food or liquid enters the airway. Especially when silent (unnoticed) or accompanied by a weak cough (inadequate airway clearance), penetration and aspiration may lead to life-threatening airway infections {McGrattan et al., 2021, PMID33822657}.

[0004] PlwSMA reporting swallowing problems may undergo a videofluoroscopic swallowing study (VFSS) or, to limit radiation exposure, a fiberoptic endoscopic swallowing assessment {Audag et al., 2019, PMID 30728931; Nacci et al., 2008, PMID 18939710}. The main purpose of the VFSS is to grade the severity of observed penetration and / or aspiration with the help of a global clinical scale (such as the "Penetration Aspiration Scale" or the "Dysphagia Outcome Severity Scale") to derive safe eating and drinking recommendations for the individual {Rosenbek et al., 1996, PMID 8721066; O'Neil et al., 1999, PMID 10341109}. These recommendations usually include avoiding dry hard foods and / or avoiding drinking thin liquids (this is why swallowing saliva carries a huge risk). However, the output of the VFSS is subjective and dependent on the examiner's experience, as discussed in Katlyn McGrattan's SMAll talk. Despite the prevalence of dysphagia in PlwSMA, it is important to note that in clinical practice, the VFSS is rare and only performed when seriously suspected (e.g., when severe swallowing problems have been reported). The VFSS is not a tool to track dysphagia longitudinally. Other patient-reported outcomes (such as the Neuromuscular Disease Swallowing Status Scale or the Sydney Swallowing Questionnaire) exist but are rarely used systematically in PlwSMA {Audag et al., 2019, PMID 30728931}.

[0005] It would therefore be desirable to provide a method of collecting swallowing data from a patient that does not incur the above-mentioned problems. Summary of the invention

[0006] At a high level, the present invention provides an apparatus and computer-implemented method for determining the number of times a subject has swallowed, for example, in a given amount of time. More specifically, each time the user reaches a predetermined point in a swallowing cycle, the user is prompted to provide input to the apparatus. Based on a series of inputs, the apparatus is able to calculate the number of times the user has swallowed.

[0007] Therefore, a first aspect of the present invention provides a diagnostic device configured to measure the number of times a subject swallows, 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, which when executed by the at least one processor causes the diagnostic device to: prompt the user via the user interface to provide user input via one or more sensors associated with the device whenever the user is at a predetermined point during a swallowing action; receive multiple user inputs via the one or more sensors, each user input corresponding to a corresponding time when the user is at the predetermined point during the swallowing action; in response to receiving each user input, generate a timestamp associated with the corresponding user input; apply a counting model to data including multiple generated timestamps, wherein the counting model is configured to calculate the number of swallows of the subject by counting the total number of timestamps in the data including multiple generated timestamps; and output the calculated number of swallows.

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

[0009] As is well known, for example, the number of swallows in a given time may be correlated with validated clinical tools for assessing dysphagia, such as the EAT-10 (Eat Assessment Tool 10) or the SSQ (Sydney Swallowing Questionnaire), both of which may also be used to perform clinical assessments. By using a diagnostic device according to the first aspect of the invention to measure swallowing volume, the progression of various muscle disabilities, such as SMA, in a subject may be effectively tracked through active testing of the subject. Use of a diagnostic device according to the first aspect of the invention may be particularly effective for assessing, for example, symptom severity (i.e., the degree of difficulty in swallowing) and the progression of bulbar muscle disabilities, such as SMA, through active testing of the subject. As described in detail later in this application, a diagnostic device according to the first aspect of the invention may use the calculated number of swallows to indicate and / or track the presence or progression of a muscle disability, such as SMA, in a subject or user.

[0010] Implementations of the diagnostic device may be used to assess swallowing of food and / or beverages. Thus, the computer readable instructions, when executed by the device, may further cause the diagnostic device to prompt a user, via a user interface, to consume a serving of food. Alternatively or additionally, the computer readable instructions may further cause the diagnostic device to prompt a user, via a user interface, to consume a beverage. The predetermined point in the swallowing action may be the beginning or end of the swallowing action. This allows for a more reliable swallow count to be obtained, as the user can more easily identify the point at which they begin or end the swallowing action.

[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 sip of food or a sip of 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 number of times required to clear the mouth of the food or beverage. Thus, the user may be prompted to take a sip of food or a sip of beverage, and provide user input each time they swallow, for the number of times it takes to clear the mouth. The computer readable instructions, when executed by the device, may cause the diagnostic device to receive user input a desired number of times, and / or receive user input for a desired time period corresponding to the swallows required by the user to clear the mouth. There may be no limit to the number of inputs that may be received or the time period over which 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 eat or take a sip of a food or a drink. Among the multiple swallowing tests, there may be at least one swallowing test in which the user is prompted to eat or take a sip of a food ("food swallowing test"), and at least one swallowing test in which the user is prompted to drink or take a sip of a drink ("beverage swallowing test"). Among the multiple swallowing tests, there may be multiple, for example, at least three food swallowing tests. Among the multiple swallowing tests, there may be multiple, for example, at least three beverage swallowing tests. The computer-readable instructions, when executed by at least one processor, may cause the diagnostic device to prompt the user to drink a sip or more sips of a drink 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 beverage swallowing tests in an alternating order.

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

[0014] In a preferred implementation, the device is or comprises a smartphone. This is advantageous because almost everyone owns a smartphone today. By implementing a computer-implemented process, such as the one described on a smartphone, the user need not be present in, for example, a hospital or other clinical setting in order to measure the number of swallows. Other kinds of diagnostic devices may be used, such as tablet computers, laptop computers, desktop computers, etc. Alternatively, the diagnostic device may be a dedicated swallowing measurement device.

[0015] The diagnostic device preferably further includes a display assembly configured to display a user interface. Preferably, the display assembly is in the form of a screen, such as a touch screen. In implementations where the display assembly includes a touch screen, the touch screen preferably includes one or more sensors associated with the device. In those cases, the sensor may include a resistive sensor, a capacitive sensor, a surface acoustic wave sensor, an infrared grid sensor, an infrared acrylic projection sensor, an optical imaging sensor, a piezoelectric sensor, and / or an acoustic pulse recognition sensor. In most cases, one or more sensors are capacitive sensors because they are most commonly used in smartphones. The working principle of a capacitive sensor is that when a person touches the screen, its electrostatic field is distorted, which is reflected in a change in capacitance.

[0016] The counting model may be configured to count the number of swallows of the subject within a predetermined time range or duration. In some cases, instead of or in addition to calculating the raw number of 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 a swallowing rate model (in addition to or in addition to the counting model) to data including a plurality of time stamps to calculate a swallowing rate. The swallowing rate model may be configured to calculate a time difference between two of the plurality of time stamps, and to calculate the swallowing rate based on the inverse of the calculated time difference. In some cases, the earlier of the two time stamps may be immediately before the later of the two time stamps. In other words, the two time stamps may be consecutive time stamps. Alternatively, there may be n time stamps between the earlier of the two time stamps and the later of the two time stamps, and the swallowing rate model is configured to calculate the swallowing rate by multiplying the inverse of the time difference by (n+1). By taking the inverse of the time difference as described above, the swallowing rate model can calculate the swallowing rate in units of swallows per second. In some cases, the swallowing rate model can be further configured to multiply the inverse of the time difference (i.e., the inverse) by sixty to obtain the swallowing rate in units of swallows per minute. It should be noted that the time difference between two consecutive timestamps may correspond to the swallowing duration. In some instances, the swallowing rate model can be configured to calculate the average swallowing duration by summing a plurality of time differences and dividing the sum by n, each time difference being the difference between two consecutive timestamps, where n is the number of time differences. The swallowing rate model can then calculate the average swallowing rate by taking the inverse of the average swallowing duration.

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

[0018] In some instances, applying the clinical interpretation model may include applying the clinical interpretation model to a plurality of calculated swallow counts, each of the calculated swallow counts being calculated in different swallowing tests. The clinical interpretation model may be configured to determine a minimum swallow count among the plurality of calculated swallow counts. The minimum swallow count may refer to a minimum number of swallows. In some instances, each of the calculated swallow counts may be calculated in different food swallowing tests. In some instances, each of the calculated swallow counts may be calculated in different food swallowing tests in which a user is prompted to take a small bite of food.

[0019] The clinical interpretation model may be configured to compare the minimum number of swallows to a predetermined value and output an indication of the presence or absence of a muscle disability, such as SMA, based on the comparison. In particular, the clinical interpretation model may be configured to determine whether the minimum number of swallows is greater than a predetermined threshold, and if it is determined that the minimum number of swallows is greater than the predetermined threshold, output an indication of the presence of a muscle disability (e.g., the user is a PlwSMA), and / or if it is determined that the minimum number of swallows is less than or equal to the predetermined threshold, output an indication of the absence of a muscle disability. The predetermined threshold may be less than or equal to 2, for example, the predetermined threshold may be 1. A PlwSMA may never or is unlikely to clear their mouth with only a single swallow after a sip. In a series of tests, healthy individuals may always or are likely to clear their mouth with only 1 swallow after a sip at least once. 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: prompting a user via a user interface to provide user input via one or more sensors associated with a device whenever the user is at a predetermined point during a swallowing action; receiving multiple user inputs via the one or more sensors, each user input corresponding to a corresponding time when the user is at a predetermined point during a swallowing action; in response to receiving each user input, generating a timestamp associated with the corresponding user input; applying a counting model to data including multiple generated timestamps, wherein the counting model is configured to calculate the number of swallows of the subject by counting the total number of timestamps in the data including multiple generated timestamps; and outputting the calculated number of swallows.

[0020] In a preferred case, the computer-implemented method of the second aspect of the present invention is performed by a processor of a diagnostic device such as the diagnostic device of the first aspect of the present invention. It should be understood that the optional features set forth above with respect to the first aspect of the present invention are equally applicable to the second aspect of the present invention, unless the context clearly indicates otherwise, or whether the combination of such features is obviously technically incompatible.

[0021] A third aspect of the invention provides a computer program comprising instructions which, when executed by a processor of a computer (or other suitable data processing apparatus), cause the processor to perform the computer-implemented method of the second aspect of the invention. Another aspect of the 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 any combination of described aspects and preferred features unless such a combination is expressly impermissible or explicitly avoided. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Embodiments of the present invention will now be described with reference to the accompanying drawings, in which:

[0024] -Figure 1 is an illustration of an example environment in which a diagnostic apparatus for assessing the number of times a subject has swallowed is provided.

[0025] - Figure 2 is a flow chart of a computer-implemented method for assessing the number of times a user has swallowed.

[0026] - Figure 3 is a flow chart of a computer-implemented method for determining an indication of the presence or absence of muscle disability, such as SMA.

[0027] - Figure 4 is a graph showing the number of swallows calculated for PlwSMA and healthy individuals.

[0028] - Figure 5 An example of a network architecture and data processing device that can be used to implement one or more illustrative aspects described herein is shown.

[0029] Detailed description with drawings

[0030] Aspects and embodiments of the present invention will now be discussed with reference to the accompanying drawings. Other aspects and embodiments will be apparent to those skilled in the art. All documents mentioned in this text are incorporated herein by reference.

[0031] In the following description of the various aspects, reference is made to the accompanying drawings which form a part hereof and in which are shown by way of illustration various embodiments in which the aspects described herein may be practiced. It should be understood that other aspects and / or embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the described aspects and embodiments.

[0032] Aspects described herein can be used for other embodiments and can be practiced or executed in various ways. In addition, it should be understood that the wording and terminology used herein are for illustrative purposes and should not be considered as restrictive. On the contrary, the phrases and terms used in this article will be given their broadest interpretation and meaning. The use of "include" and "comprise" and their variations is intended to cover the items listed thereafter and their equivalents, as well as other items and their equivalents. The use of the terms "install", "connect", "couple", "locate", "engage" and similar terms is intended to include direct and indirect installation, connection, coupling, positioning and engagement.

[0033] The systems, methods, and devices described herein provide a diagnostic device and computer-implemented methods for evaluating, measuring, or determining the number of swallows made by a patient, for example, a patient with bulbar muscle dysfunction, such as a particular SMA. In some cases, the diagnostic device may be in the form of a mobile device, particularly a smartphone, having a specific software application installed thereon. The software application may be configured to execute (or cause a processor of the mobile device to execute) a corresponding computer-implemented method.

[0034] In some cases, the diagnostic obtains or receives sensor data from one or more sensors associated with the mobile device as the subject interacts with the software application using the mobile device. In some cases, the sensor may be within the mobile device. In some cases, the number of times the patient swallows is derived, calculated, or extracted from the received or obtained sensor data. In some cases, an assessment of the severity and progression of symptoms of muscle disability, particularly SMA, in the subject may be determined based on the extracted sensor features.

[0035] In an implementation of the present invention, the diagnostic device may prompt the subject to perform a diagnostic task. In some cases, the diagnostic task is anchored in an established method and standardized test, or the diagnostic task is modeled after an established method and standardized test. In some cases, in response to the subject performing the diagnostic task, the diagnosis obtains or receives sensor data via one or more sensors. In some cases, the sensor may be in a mobile device or wearable sensor worn by the subject. In some cases, sensor features associated with symptoms of muscle disability, particularly SMA, are extracted from the received or obtained sensor data. In some cases, an assessment of the severity and progression of symptoms of muscle disability, particularly SMA, of the subject is determined based on the extracted features of the sensor data.

[0036] Assessment of symptom severity and progression of muscle disability, particularly SMA, using diagnostics according to the present disclosure correlates well with clinical outcome-based assessments and can therefore replace clinical subject monitoring and testing. Example diagnostics according to the present disclosure can be used outside of a clinical setting and therefore have advantages for subjects in terms of cost, ease of subject monitoring, and convenience. This facilitates frequent, particularly daily, subject monitoring and testing, thereby providing a better understanding of the disease stage and providing disease insights useful to both the clinical and research communities. Example diagnostics according to the present disclosure can provide earlier detection of subtle changes in swallowing ability that may indicate the presence or progression of muscle disability, particularly SMA, in a subject, and can therefore be used for better disease management, including personalized therapy.

[0037] Figure 1is a diagram of an example environment in which a diagnostic device 105 is used to evaluate the number of swallows made by a subject 110 having, for example, muscle disability, particularly SMA. In some cases, device 105 can be a smartphone, smart watch, or other mobile computing device. Device 105 includes a display screen 160. In some cases, display screen 160 can be a touch screen. Device 105 includes at least one processor 115 and a memory 125 storing computer instructions for a symptom monitoring application 130, which when executed by at least one processor 115 causes device 105 to evaluate one or more swallows made by subject 110, such as a patient having muscle disability, particularly SMA, and / or determine an indication of the presence or absence of muscle disability, such as SMA. Device 105 receives a plurality of sensor data via one or more sensors associated with device 105. In some cases, the one or more sensors associated with the device are at least one of sensors disposed within the device or sensors worn by the subject and configured to communicate with the device. In Figure 1 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 .

[0038] The device 105 extracts the number of swallows made by the subject 110 from the received first sensor data.

[0039] Device 105 determines the number of swallows made by subject 110 based on the extracted features. In some cases, device 105 sends the extracted features to server 150 via network 180. In some cases, device 105 sends the first sensor data to server 150 via network 180. Server 150 includes at least one processor 155 and memory 161 storing computer instructions for symptom assessment application 170, which when executed by server processor 155 causes processor 155 to determine the number of swallows made by subject 110 based on the extracted features received by server 150 from device 105. In some cases, symptom assessment application 170 may determine the number of swallows made by subject 110 based on the extracted features of the sensor data received from device 105 and a subject database 175 stored in memory 160. Multiple swallowing tests may be performed, with the first sensor data collected and processed in each test so that multiple swallowing times may be determined. Symptom assessment application 170 may further determine an indication of the presence or absence of muscle disability, such as SMA, from the determined one or more swallowing times, and may output the indication. In some cases, subject database 175 may include subject data and / or clinical data. In some cases, subject database 175 may include in-clinic and sensor-based measurements of the number of times subject 110 has swallowed. In some cases, subject database 175 may be independent of server 150. In some cases, server 150 sends the determined one or more swallowing times and / or the indication of the presence or absence of muscle disability to device 105. In some cases, device 105 may output the swallowing times. In some cases, device 105 may communicate information to subject 110 based on the assessment. In some cases, the assessment of the number of swallowing times or the indication of the presence or absence of muscle disability may be communicated to a clinician who may determine a personalized therapy for subject 110 based on the assessment.

[0040] In some cases, the computer instructions for the condition monitoring application 130, when executed by the at least one processor 115, cause the device 105 to determine the number of swallows made by the subject 110 based on active testing of the subject 110. The device 105 prompts the subject 110 to perform one or more tasks. The number of swallows can be calculated for each task. In some cases, prompting the subject to perform one or more diagnostic tasks includes prompting the subject 110 to eat or take a small bite of a food, or drink or take a small sip of a beverage, and tapping the touch screen (or equivalent sensor) at the beginning and / or end of each swallow. The prompt may further specify the food or beverage to be eaten / drinked and swallowed.

[0041] In response to subject 110 performing each of the one or more diagnostic tasks, diagnostic device 105 receives a plurality of sensor data via one or more sensors associated with device 105, the sensor data including a series of time stamps corresponding to the time at which the user indicated (via the sensor) to swallow. Device 105 extracts from the received sensor data for each diagnostic task the number of times the user has swallowed, for example, within a specific time range. Thus, a plurality of swallowing times may be determined. Symptoms of muscle disability, particularly SMA, of subject 110 may include symptoms that affect the ability of subject 110 to swallow.

[0042] Thus, the device may further determine the presence or absence of muscle disability, such as SMA, based on one or more swallowing times, for example by determining a minimum or least number of swallows among a plurality of swallowing times.

[0043] Figure 2 Shown for use based on Figure 1 The example apparatus 105 is an example method of actively testing a subject to assess the number of times a user of the subject swallows. Figure 2 refer to Figure 1 To describe, it should be noted that Figure 2 The method steps may be performed by other systems. The computer-implemented method includes 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 is at a predetermined point in the swallowing action (such as the beginning) in step 205. The method includes receiving a plurality of sensor data via one or more sensors in response to the subject performing one or more tasks (step 210), the one or more sensors may be in the form of capacitive sensors in the touch screen of the display assembly 160.

[0044] Then, in step 215, the counting model is applied to the data including the multiple time stamps. The features of the counting model have been explained in detail elsewhere in this patent application and will not be repeated here for the sake of brevity.

[0045] In step 220, the swallow count is output, for example by processor 107 generating instructions that, when executed by display component 160 of apparatus 105, cause display component 160 to display the swallow count. Alternatively, the calculated swallow count may be transmitted to server 150, as described elsewhere herein.

[0046] As described above, assessment of symptom severity and progression of muscle disability, particularly SMA, using diagnostics according to the present disclosure correlates well with assessments based on clinical outcomes and can therefore replace clinical subject monitoring and testing.

[0047] Figure 3 shows an example method for using Figure 1 The example device 105 actively tests the subject to determine an indication of the presence or absence of SMA in the subject. Figure 3 refer to Figure 1 To describe, it should be noted that Figure 3 The method steps may be performed by other systems. The computer-implemented method includes calculating a plurality of swallowing times in step 225, each swallowing time being calculated based on a reference Figure 2 The method described is determined. That is, each swallowing number may be calculated in a separate swallowing test. Multiple swallowing tests may include only a swallowing test that prompts the user to take a small sip of a food, and may include at least 3 food swallowing tests. Between each of these swallowing tests, the user may have been prompted to take a small sip of a beverage. In step 230, the computer-implemented method includes determining the minimum number of swallows among the multiple swallowing numbers. Then, 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, then in step 245, the computer-implemented method includes outputting an indication of the presence of SMA. If the calculated number of swallows is determined to be less than or equal to the predetermined threshold, then in step 250, the computer-implemented method includes outputting an indication of the absence of SMA.

[0048] The predetermined threshold may be less than or equal to 2, for example, the predetermined threshold may be 1. That is, a minimum swallowing number of >1 may indicate that the user is a PlwSMA, and a minimum swallowing number of ≤1 may indicate that the user is not a PlwSMA. Figure 4 Provide explanation. Figure 4 is a graph showing the determined minimum number of swallows for PlwSMA and healthy individuals. The graph indicates that all PlwSMA had a test result of a minimum number of swallows >1, while all healthy individuals had a test result of a minimum number of swallows ≤1.

[0049] Figure 5 A method is shown that can be used to implement one or more illustrative aspects described herein (such as Figure 1 and Figure 2301 ) and an example of a network architecture and data processing device. Various network nodes 303, 305, 307, and 309 may be interconnected via a wide area network (WAN) 301 (such as the Internet). Other networks may also or alternatively be used, including a private intranet, a corporate network, a LAN, a wireless network, a personal network (PAN), etc. Network 301 is for illustrative purposes and may be replaced with fewer or other computer networks. A local area network (LAN) may have one or more of any known LAN topology and may use one or more of a variety of different protocols, such as Ethernet. Devices 303, 305, 307, 309 and other devices (not shown) may be connected to one or more networks via twisted pair, coaxial cable, optical fiber, radio waves, or other communication media.

[0050] The term "network" as used herein and depicted in the accompanying drawings refers not only to a system in which remote storage devices are coupled together via one or more communication paths, but also to independent devices that may occasionally be coupled to a system having storage functions. Thus, the term "network" includes not only a "physical network" but also a "content network", which consists of data (attributed to a single entity) residing in all physical networks.

[0051] 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 database and control software for performing one or more illustrative aspects described herein. The data server 303 may be connected to the web server 305, through which users interact and obtain data upon request. Alternatively, the data server 303 itself may act as a web server and be directly connected to the Internet. The data server 303 may be connected to the web server 305 via a network 301 (e.g., the Internet), via a direct or indirect connection, or via some other network. Users may interact with the data server 303 using a remote computer 307, 309 (e.g., using a web browser) via one or more externally disclosed websites hosted by the web server 305 to connect to the data server 303. The client computers 307, 309 may be used together with the data server 303 to access data stored therein, or may be used for other purposes. For example, as is known in the art, a user may access the web server 305 from a client device 307 using an Internet browser or by executing a software application that communicates with the web server 305 and / or data server 303 over a computer network (such as the Internet). In some cases, the client computer 307 may be a smartphone, smart watch, or other mobile computing device, and may implement a diagnostic device such as Figure 1 In some cases, the data server 303 may implement a server such as Figure 1Server 150 is shown.

[0052] The server and application can be combined on the same physical computer and retain separate virtual or logical addresses, or they can reside on separate physical computers. Figure 1 Only one example of a network architecture that can be used is shown, 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 functionality they provide, as further described herein. For example, the services provided by the network server 305 and the data server 303 may be combined on a single server.

[0053] Each component 303, 305, 307, 309 can 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 a RAM 313, a ROM 315, a network interface 317, an input / output interface 319 (e.g., a keyboard, a mouse, a display, a printer, etc.) and a 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 instructing the data server 303 to perform aspects described herein, and other application software 327 that provides assistance, support and / or other functions, which may or may not be used in conjunction with other aspects described herein. The control logic may also be referred to as data server software 325 in this article. The functionality of the data server software may refer to a combination of operations or decisions made automatically based on rules encoded into the control logic, operations made manually by users providing input to the system, and / or automatic processing based on user input (e.g., queries, data updates, etc.).

[0054] The memory 321 may also store data for performing one or more aspects described herein, including a first database 329 and a second database 331. In some cases, the first database may include the second database (e.g., as a separate table, report, etc.). That is, depending on the system design, information may be stored in a single database or divided into different logical, virtual or physical databases. The devices 305, 307, 309 may have an architecture similar to or different from that described with respect to the device 303. Those skilled in the art will appreciate that the functionality of the data processing device 303 (or devices 305, 307, 309) as described herein may be distributed across multiple data processing devices, for example, to distribute processing loads between multiple computers to separate processing performed based on geographic location, user access level, quality of service (QoS), etc.

[0055] One or more aspects described herein may be embodied in computer-usable or readable data and / or computer-executable instructions executed by one or more computers or other devices described herein, such as in one or more program modules. Typically, program modules include routines, programs, targets, components, data structures, etc., which perform specific tasks or implement specific abstract data types when executed by a processor in a computer or other device. Modules may be written in a source code programming language and then compiled to execute the module, or modules may be written in a scripting language (such as, but not limited to, HTML or XML). Computer-executable instructions may be stored on a computer-readable medium, such as a hard disk, an optical disk, a removable storage medium, a solid-state memory, a RAM, etc. As will be appreciated by those skilled in the art, the functions of the program modules may be combined or distributed as needed in various embodiments. In addition, the functions may be embodied in firmware or equivalent hardware (such as an integrated circuit, a field programmable gate array (FPGA), etc.) in whole or in part. Specific data structures may be used to more effectively implement one or more aspects, and such data structures are included within the scope of computer-executable instructions and computer-usable data described herein.

[0056] The features disclosed in the foregoing description, or in the following claims, in terms of the manner of expressing or implementing the disclosed functions in their specific forms, or in terms of the methods or processes for obtaining the disclosed results, may be appropriately used alone in their various forms, or in any combination to implement the present invention.

[0057] Although the present invention has been described in conjunction with the above exemplary embodiments, many equivalent modifications and variations will be apparent to those skilled in the art when this disclosure is given. Therefore, the above exemplary embodiments of the present invention are considered to be illustrative rather than restrictive. Various changes may be made to the described embodiments without departing from the spirit and scope of the present invention.

[0058] For the avoidance of any doubt, any theoretical explanations provided herein are intended to improve the reader's understanding. The inventors do not wish to be bound by any of these theoretical explanations.

[0059] Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0060] Throughout the specification, including the following claims, unless the context requires otherwise, the words "comprise" and "include" and variations such as "comprises and comprising" and "including", will be understood to imply the inclusion of stated integers or steps or groups of integers or steps but not the exclusion of any other integers or steps or groups of integers or steps.

[0061] It must 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" in relation to a numerical value is optional and means, for example, + / - 10%.

Claims

1. A diagnostic device configured to count the number of swallowing times of a user, the device comprising: at least one processor; user interface; one or more sensors associated with the device; as well as a memory storing computer readable instructions that, when executed by the at least one processor, cause the diagnostic device to perform a swallowing test that causes the diagnostic device to: 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 is at a predetermined point during a swallowing maneuver; receiving a plurality of inputs via the one or more sensors, each user input corresponding to a respective time at which the user was at a predetermined point during the swallowing motion; In response to receiving each user input, generating a timestamp associated with the respective user input; applying a counting model to data comprising a plurality of generated timestamps, wherein the counting model is configured to calculate a number of swallows of a user by counting a total number of timestamps in the data comprising the plurality of generated timestamps; as well as Output the calculated number of swallows.

2. The diagnostic device according to claim 1, wherein: The diagnostic device includes a smartphone including a display component configured to display the user interface.

3. The diagnostic device according to claim 2, wherein: The display assembly includes a touch screen, the touch screen including the one or more sensors, and wherein the user input is a touch of the screen detectable by the one or more sensors. The diagnostic device of claim 3 , wherein the one or more sensors comprise capacitive sensors.

5. The diagnostic device according to any one of claims 1 to 4, 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 serving of food.

6. The diagnostic device according to any one of claims 1 to 5, wherein: The computer readable instructions, when executed by the at least one processor, further cause the diagnostic device to prompt the user to consume a beverage via the user interface.

7. The diagnostic device according to any one of claims 1 to 6, wherein: The predetermined point during the swallowing action is the beginning or the 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. 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 calculated swallowing times, wherein the clinical interpretation model outputs an indication of the presence or absence of muscle disability.

10. The diagnostic apparatus of claim 9, wherein the clinical interpretation model is configured to determine a minimum number of swallows among the plurality of calculated swallowing numbers.

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

12. A diagnostic device according to claim 11, wherein the clinical interpretation model is configured to determine whether the minimum number of swallows is greater than a predetermined threshold, and if it is determined that the minimum number of swallows is greater than the predetermined threshold, output an indication of the presence of the muscle disability, and if it is determined that the minimum number of swallows is less than or equal to the predetermined threshold, output an indication of the absence of the muscle disability. The diagnostic device according to claim 12 , wherein the predetermined threshold is 1.

14. A computer-implemented method for counting the number of swallowings of a subject, the computer-implemented method comprising: prompting the subject via the user interface to provide user input via one or more sensors associated with the diagnostic device each time the user is at a predetermined point during a swallowing maneuver; receiving a plurality of inputs via the one or more sensors, each user input corresponding to a respective time at which the user was at a predetermined point during the swallowing motion; In response to receiving each user input, generating a timestamp associated with the respective user input; A counting model is applied to data including a plurality of generated timestamps, wherein the counting model is configured to calculate a number of swallows of a user by counting a total number of timestamps in the data including the plurality of generated timestamps.

15. The computer-implemented method of claim 14, wherein the computer-implemented method further comprises the steps of: A clinical interpretation model is applied to the calculated number of swallows, wherein the clinical interpretation model outputs an indication of the presence or absence of muscle disability or an indication of the progression of muscle disability.

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

17. The computer-implemented method of claim 14 or claim 15, wherein the steps of prompting the subject, receiving the user input, and generating the timestamp are performed by a processor of a diagnostic device, and wherein the step of applying the counting model is performed by a processor of a server, wherein the diagnostic device is configured to transmit the generated timestamp to the server, and wherein the diagnostic device comprises: at least one processor; user interface; one or more sensors associated with the device; as well as a memory storing computer readable instructions that, when executed by the at least one processor, cause the diagnostic device to perform a swallowing test that causes the diagnostic device to: 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 is at a predetermined point during a swallowing maneuver; receiving, via the one or more sensors, a plurality of user inputs, each user input corresponding to a respective time at which the user was at a predetermined point during a swallowing motion; In response to receiving each user input, a timestamp associated with the respective user input is generated.

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