Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea

NCT02834767 | Completed FDA Device

• 1 other identifier: IRB201600916
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Maximum Tongue Pressure Force (MTPF)

  Maximum pressure generated (in Newtons) during tongue protrusion

  Pre to post treatment (approximately 10 weeks)

Secondary Outcomes (2)

• Snoring Severity

  Pre to post treatment (approximately 10 weeks)

• Apnea-Hypopnea Index

  Pre to post treatment (approximately 10 weeks)

Study Arms (4)

Group 1 Primary Snoring Treatment

EXPERIMENTAL

Intervention: Eight weeks of supervised use of the genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device.

Device: Genioglossis Strength Trainer

Group 2 Primary Snoring Placebo

PLACEBO COMPARATOR

Intervention: Eight weeks of supervised use of the placebo genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device.

Device: Placebo Genioglossis Strength Trainer

Group 3 Primary OSA Treatment

EXPERIMENTAL

Intervention: Eight weeks of supervised use of the genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device.

Device: Genioglossis Strength Trainer

Group 4 Primary OSA Placebo

PLACEBO COMPARATOR

Intervention: Eight weeks of supervised use of the placebo genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device.

Device: Placebo Genioglossis Strength Trainer

Interventions

Genioglossis Strength Trainer DEVICE

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).

Also known as: Tongue Strength Trainer

Group 1 Primary Snoring Treatment; Group 3 Primary OSA Treatment

Placebo Genioglossis Strength Trainer DEVICE

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).

Also known as: Placebo Tongue Strength Trainer

Group 2 Primary Snoring Placebo; Group 4 Primary OSA Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Snoring + AHI \< 5/hr (primary snoring group)
• AHI ≥ 5/hour and less than 30/hour (OSA group)
• Ability to understand and perform training.
• Ability to return to the UF Health Sleep Center 1X per week for the (8 week) duration of the study.

You may not qualify if:

• Pregnancy
• Prior Upper airway surgery (nasal surgery is allowed)
• Severe nasal obstruction
• BMI \> 40 kg/M2
• Use of CPAP \> 12 cm H2O \*
• Use of potent narcotics
• History of arrhythmia (other than PACs and PVCs)
• Coronary artery disease or congestive heart failure (patients with controlled hypertension will be included),
• Moderate to severe lung disease
• History of pneumothorax.
• severe daytime sleepiness (falling asleep while driving or Epworth Sleepiness Scale \> 14),
• History of chronic short sleep duration (\< 5 hours).

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Sleep Center

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Richard Berry, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 15, 2016
• Study Start: October 1, 2016
• Primary Completion: May 4, 2019
• Study Completion: May 4, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)