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Wearable Monitoring Systems for Swallowing Function and 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)
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
233 Previous Clinical Trials
71,303 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
95 Previous Clinical Trials
21,233 Total Patients Enrolled
Georgia A. Malandraki, PhDPrincipal Investigator - Professor
Purdue University
Chi Hwan Lee, PhDPrincipal InvestigatorAssociate Professor