NCT04243577

Wearable Monitoring Systems for Swallowing Function and Disorders

Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Purdue University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Deglutition Disorders

Interventions

Type	Name	Description
DEVICE	Tele-EaT Sensors	Two iterations of a wearable surface EMG (sEMG) sensors patch we developed will be tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The second iteration is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants will perform standardized swallow tasks while wearing the device.
DEVICE	Conventional Sensors	Conventional sensors will include snap-on wired electrodes as the control condition. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.

Timeline

• Start date: 2018-09-11
• Primary completion: 2023-03-31
• Completion: 2023-07-25
• First posted: 2020-01-28
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study