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Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea

NCT02834767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-02-06

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence exists that some behavioral (e.g. exercise based) therapies may assist in lessening the severity of this disorder. The proposed investigation will examine the effects of eight weeks of genioglossus muscle strength training on measures of snoring and OSA severity as well as genioglossus protrusive muscle strength.

Conditions

  • Snoring
  • Sleep Apnea, Obstructive

Interventions

DEVICE

Genioglossis Strength Trainer

The genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. The device can be set to a specific pressure resistance ranging from 10 to 40 Newtons. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter).

DEVICE

Placebo Genioglossis Strength Trainer

The placebo genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. Whereas the pressure loaded spring in the active trainer can be set to a wide range of pressures, the placebo trainer has a maximum resistance of 5 Newtons. The device is set to a specific pressure resistance of 5 Newtons at all times. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter).

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Richard Berry, M.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-05-04
Completion
2019-05-04
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02834767 on ClinicalTrials.gov