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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.

Eligible Conditions

Swallowing Disorders
Muscle Tension Dysphagia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post each experiment (i.e., 1 hour after the sensors have been placed)

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