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Tongue Protrusion Force: A Pilot Study

NCT02781701 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-02-08

No results posted yet for this study

Summary

From Weill Cornell Medical College Center for Sleep Medicine, the investigators will recruit patients (N = 25) with previously documented moderate to severe OSA. They will receive an all-night in-home sleep study to document the severity of their OSA immediately before starting the training regimen. Scales and questionnaires measuring sleepiness, snoring, fatigue, and insomnia will be administered prior to starting the training and repeated after six weeks of training. Subjects may be removed from the study due to failing to adhere to the training regimen at anytime via remote data monitoring. The principal measure of the efficacy of the treatment will be the change in RDI, the number of abnormal breathing events per hour of sleep.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

DEVICE

Tongue Trainer

The strength of participants tongue will be measured and participants will be shown how to perform tongue training exercises using a special device. Participants will be given instructions on how to perform a workout for the tongue. Each day once in the morning (am) and once in the afternoon/evening (pm), participants will train with the device and have a "tongue workout" that lasts about 10 minutes. Therefore, participants will work out about 20 minutes a day for 6 weeks.

Sponsors & Collaborators

  • Cornell University

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Matthew Ebben, Ph. D. · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781701 on ClinicalTrials.gov