Wearable Monitoring Systems for Swallowing Function and Disorders

Purdue University

Status and phase: Completed; Early Phase 1

Conditions: Deglutition Disorders

Treatments: Device: Tele-EaT Sensors; Device: Conventional Sensors

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04243577

1807020788

1R21EB026099-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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):

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors

Other group

Description:

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).

Treatment:

Device: Conventional Sensors

Device: Tele-EaT Sensors

Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors

Other group

Description:

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.

Treatment:

Device: Conventional Sensors

Device: Tele-EaT Sensors