← Back to Search

Tele-EaT Sensors for Swallowing Disorders

Q: Does this research include any older individuals in the sample size?

The age limit for this study is 90 years old, meaning that as long as patients are over 18, they are eligible for the trial.

Q: Are there any specific requirements for those who want to be a part of this research?

This clinical trial is searching for 200 individuals that currently experience esophageal dysphagia. The ideal candidate will be between the ages of 18 and 90. In addition to this age requirement, it is necessary that patients meet the following inclusion criteria: Age 18-90 years of age, Age 18-30 OR 50-90 years of age, No history of a neurological disorder, A score of &#x3C;3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia)., A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA)., A

Q: How many total test subjects are involved in this experiment?

That is correct. The clinical trial is still recruiting patients, as shown by the most recent update on clinicaltrials.gov. The posting date was September 11th, 2018, and the 200 patients are needed at a single site.

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

Awards & highlights

Study Summary

This trial will develop and test new wearable sensors to help people with swallowing disorders, to see if they work as well as traditional sensors.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Normalized task-related sEMG amplitude (signal quality parameter)

Peak pressure during maximum lingual press and swallows (signal quality parameter)

Signal to Noise ratio (signal quality parameter)

Secondary outcome measures

Adverse effects and safety

Ease of use/comfort

Onset of sEMG activity relative to onset of swallow apnea

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental SensorsExperimental Treatment1 Intervention

This arm will include the use of the experimental wearable sensors we are developing.

Group II: Conventional SensorsActive Control1 Intervention

This arm will include the use of the conventional sensors: regular snap on sEMG electrodes and IOPI device bulb.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tele-EaT Sensors

2018

Completed Early Phase 1

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Purdue UniversityLead Sponsor

224 Previous Clinical Trials

72,662 Total Patients Enrolled

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH

89 Previous Clinical Trials

19,682 Total Patients Enrolled

Georgia A. Malandraki, PhDPrincipal Investigator - Associate Professor

Purdue University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include any older individuals in the sample size?

"The age limit for this study is 90 years old, meaning that as long as patients are over 18, they are eligible for the trial."

Answered by AI

Are there any specific requirements for those who want to be a part of this research?

"This clinical trial is searching for 200 individuals that currently experience esophageal dysphagia. The ideal candidate will be between the ages of 18 and 90. In addition to this age requirement, it is necessary that patients meet the following inclusion criteria: Age 18-90 years of age, Age 18-30 OR 50-90 years of age, No history of a neurological disorder, A score of <3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia)., A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA)., A"

Answered by AI

How many total test subjects are involved in this experiment?

"That is correct. The clinical trial is still recruiting patients, as shown by the most recent update on clinicaltrials.gov. The posting date was September 11th, 2018, and the 200 patients are needed at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Wearable Monitoring Systems for Swallowing Function and Disorders

Georgia A. Malandraki 2018. "Wearable Monitoring Systems for Swallowing Function and Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04243577.