Wearable Monitoring Systems for Swallowing Function and Disorders

Overseen by Chi Hwan Lee, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Purdue University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing wearable devices that help doctors remotely monitor and manage rehabilitation for people with swallowing problems. The goal is to see if these new devices work as well or better than the current wired sensors. The study will also look at how comfortable and satisfied patients are with these new devices.

Research Team

Georgia A. Malandraki, PhD

Principal Investigator

Professor

Chi Hwan Lee, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

Inclusion Criteria

You must be between 18 and 30 years old or between 50 and 90 years old.

You have no history of difficulty swallowing.

You have never had a neurological disorder before.

Treatment Details

Interventions

• Conventional Sensors (Behavioural Intervention)
• Tele-EaT Sensors (Behavioural Intervention)

Participant Groups

Group I: Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors Experimental Treatment 2 Interventions

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 II: Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Mitchell E. Daniels, Jr.

Purdue University

Chief Executive Officer since 2013

BS in Chemical Engineering from Purdue University

Dr. Elizabeth Topp

Purdue University

Chief Medical Officer since 2020

MD from Harvard Medical School

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Dr. Bruce J. Tromberg

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Chief Executive Officer since 2019

PhD in Biomedical Engineering from the University of California, Irvine

Dr. Nina F. Schor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Chief Medical Officer since 2023

MD from Harvard Medical School