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Tele-EaT Sensors for Swallowing Disorders

Phase < 1
Waitlist Available
Led By Georgia A. Malandraki, PhD
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post each experiment (i.e., 1 hour after the sensors have been placed)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post each experiment (i.e., 1 hour after the sensors have been placed) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
Signal to Noise Ratio (Signal Quality Parameter)
Secondary study objectives
Adverse Effects and Safety
Ease of Use/Comfort

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Experimental (Tele-EaT) Sensors First, Then Conventional SensorsExperimental Treatment2 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) SensorsExperimental Treatment2 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tele-EaT Sensors
2018
Completed Early Phase 1
~70
Conventional Sensors
2018
Completed Early Phase 1
~70

Find a Location

Who is running the clinical trial?

Purdue UniversityLead Sponsor
230 Previous Clinical Trials
70,944 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
91 Previous Clinical Trials
19,952 Total Patients Enrolled
Georgia A. Malandraki, PhDPrincipal Investigator - Professor
Purdue University
~10 spots leftby Oct 2025
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