Wearable Monitoring Systems for Swallowing Function and Disorders

Early Phase 1

Completed

Conditions: Deglutition Disorders

Interventions: Device: Tele-EaT Sensors
Device: Conventional Sensors

Registration Number: NCT04243577

Lead Sponsor: Purdue University

Brief Summary: Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

Inclusion Criteria

Inclusion criteria for healthy adults:

Age 18-30 OR 50-90 years of age
No history of dysphagia
No history of a neurological disorder
A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA):
A score of <3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Inclusion criteria for patients with dysphagia:

Age 18-90 years of age
Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease).
A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA).
A score of ≥3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Exclusion Criteria

• Significant cognitive impairment (a score in the moderate-severe range on MoCA):

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors	Tele-EaT Sensors	Group A participants will complete the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then will repeat the exact same experimental protocol (exact same swallow trials) with the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors	Conventional Sensors	Group A participants will complete the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then will repeat the exact same experimental protocol (exact same swallow trials) with the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors	Tele-EaT Sensors	Group B participants will complete the experimental protocol (swallow trials) with the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then will repeat the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors	Conventional Sensors	Group B participants will complete the experimental protocol (swallow trials) with the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then will repeat the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.

Primary Outcome Measures

Name	Time	Method
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)	Post each experiment (i.e., 1 hour after the sensors have been placed)	Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome.
Signal to Noise Ratio (Signal Quality Parameter)	Post each experiment (i.e., 1 hour after the sensors have been placed)	Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome.

Secondary Outcome Measures

Name	Time	Method
Ease of Use/Comfort	Post each experiment (i.e., 1 hour after the sensors have been placed)	Ease-of-use/comfort will be examined using a survey also devised by the investigators (using a positive centered 5-point Likert scale) with questions about ease-of-use/comfort after each experiment with each device. This survey includes statements related to the participants' ease-of-use/comfort during the experimental protocol (e.g., I was comfortable while the experimenter placed the sensors on my skin). The answers will be rated on a 10-point scale (i.e., 1 = extremely uncomfortable, 10 = extremely comfortable). Higher values indicate better or higher satisfaction/comfort scores. Total scores will be compared across conditions/devices tested. For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60).
Adverse Effects and Safety	Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal)	Safety will be examined by documenting the incidence of skin irritations and pain in the subjects. A visual inspection form including a binary scale (YES/NO) has been devised by the investigators (no formal name) and will be used by a rater who will thoroughly inspect the participants' submandibular skin before and after each experiment. For any irritation or change in appearance YES will be selected and the type of irritation will be descriptively recorded (e.g., red skin). Pain is also rated in the same way through a question to the participants. This form will be completed by a rater who is not part of the data collection process and who is blinded to sensors type to avoid any bias.The number of YESs will be used to calculate the incidence of these adverse effects in the sample.