Tongue Protrusion Force: A Pilot Study

NCT02781701 | Withdrawn FDA Device

• 1 other identifier: 1602017027
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• RDI

  RDI (the sum of apneas, hypopneas, and milder, more subtle sleep disruptions known as respiratory effort related arousals, or RERAs, that can still lead to sleep fragmentation).

  Six weeks

Secondary Outcomes (3)

• TPFmax

  Six Weeks

• AHI

  Six Weeks

• dur50%

  Six weeks

Study Arms (1)

Tongue Trainer

EXPERIMENTAL

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.

Device: Tongue Trainer

Interventions

Tongue Trainer DEVICE

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.

Tongue Trainer

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 21 to 70
• At home confirmation of moderate to severe OSA (AHI 15-60)
• BMI less than or equal to 35
• Not currently on a weight loss plan and no intention of beginning a weight loss regimen during the duration of the study
• If not currently treated for OSA (AHI 15-20), not planning on starting treatment for OSA during the duration of the study
• Willing to have a diagnostic sleep study before the training
• Willing to have a diagnostic sleep study after the training
• Willing to perform tongue training exercises twice daily for 6 weeks
• Willing to keep a sleep diary

You may not qualify if:

• Dental problems, e.g., less than a full complement of front teeth, loose front teeth, brittle teeth, by history
• Temporomandibular joint (TMJ) disorder by history
• Jaw, neck, or facial muscle pain or discomfort by history
• Consumes more than one alcoholic beverage per day and unwilling to reduce alcohol consumption to no more than one alcoholic beverage per day (muscle relaxant)
• On benzodiazepine medication (or specific muscle relaxant)
• Sleeps less than 5 hours per night on average (sleep deprivation can weaken UA)
• Pregnant
• Has had an upper airway surgical procedure for sleep apnea below the level of the nasopharynx
• Non-English speaker or illiterate

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Cornell University: collaborator

Study Sites (1)

Weill Cornell Medical College Center for Sleep

New York, New York, 10065, United States

Location

Related Publications (17)

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  PMID: 18949106 BACKGROUND

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  PMID: 19234106 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Matthew Ebben, Ph. D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 24, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)