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Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea

Primary Purpose

Snoring, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genioglossis Strength Trainer
Placebo Genioglossis Strength Trainer
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Snoring

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • University of Florida Sleep Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 1 Primary Snoring Treatment

Group 2 Primary Snoring Placebo

Group 3 Primary OSA Treatment

Group 4 Primary OSA Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum Tongue Pressure Force (MTPF)
Maximum pressure generated (in Newtons) during tongue protrusion

Secondary Outcome Measures

Snoring Severity
Snoring sensor recording snoring frequency and amplitude during sleep
Apnea-Hypopnea Index
Episodes of apnea and/or hypopnea scored during the course of sleep study

Full Information

First Posted
July 13, 2016
Last Updated
February 4, 2020
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02834767
Brief Title
Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea
Official Title
Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 4, 2019 (Actual)
Study Completion Date
May 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to result in upper airway closure in patients with structurally susceptible upper airways. The genioglossus (GG, tongue) muscle plays an important role in maintaining upper airway patency. The GG is responsible for tongue protrusion and stiffens the tongue and prevents posterior tongue displacement and upper airway closure. The GG is a phasic respiratory muscle. One can demonstrate inspiratory bursts in GG EMG activity slightly preceding the onset of inspiratory activity of respiratory pump muscles. The inspiratory bursts of GG activity also increase in response to negative pressure in the upper airway to help maintain upper airway patency. In some OSA patients this response is blunted. While one study did not find a difference in protrusion muscle strength between a group of OSA patients (apnea hypopnea index, AHI = 20/hour) and normal controls (Mortimore et al) there was wide variability in muscle strength at similar AHI values. Another study (Oh et al) did find a correlation between tongue protrusion strength and the apnea index (lower strength, higher apnea index). It is hypothesized that strength training of the GG will reduce snoring and sleep apneas by augmenting the resting GG tone and enhancing the ability of the muscle to respond to negative upper airway pressure. Training of upper airway muscles including the tongue is often used in rehabilitation of patients with prior cerebrovascular accidents or damage due to surgical resection for cancer. Typically, the patient presses the tongue against the back of the upper teeth (direction both upward and forward). However, it is believed that tongue protrusion is best trained by active forward protrusion of the tongue between the teeth under load. To facilitate GGs training participants will push a spring loaded piston forward with the tongue. The piston fits inside an outer chamber. The piston can also be connected to a force measuring device to estimate protrusive tongue force. Two groups of participants will be examined: Group 1: primary snoring and Group 2: mild to moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 40 Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle dysfunction. This preliminary investigation consists of a randomized controlled trial (training versus sham training) with two months of daily training (5 out of 7 days each week). A home sleep study (including EEG) will be performed before and following the training. The change in the apnea-hypopnea index adjusted for sleep stage and body position will be compared. Use of home sleep studies will dramatically reduce the cost of the study. A sleep technologist will educate subjects on performance of training maneuvers and meet with them weekly to observe the subject's technique and measure tongue strength. A training log will be kept by the subjects using training schedule sheets and training will be directly monitored at least 2 times weekly through with a study clinician (electronically via facetime, skype or by direct observation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Sleep Apnea, Obstructive

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Primary Snoring Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 Primary Snoring Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group 3 Primary OSA Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 4 Primary OSA Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Genioglossis Strength Trainer
Other Intervention Name(s)
Tongue Strength Trainer
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Placebo Genioglossis Strength Trainer
Other Intervention Name(s)
Placebo Tongue Strength Trainer
Intervention Description
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).
Primary Outcome Measure Information:
Title
Maximum Tongue Pressure Force (MTPF)
Description
Maximum pressure generated (in Newtons) during tongue protrusion
Time Frame
Pre to post treatment (approximately 10 weeks)
Secondary Outcome Measure Information:
Title
Snoring Severity
Description
Snoring sensor recording snoring frequency and amplitude during sleep
Time Frame
Pre to post treatment (approximately 10 weeks)
Title
Apnea-Hypopnea Index
Description
Episodes of apnea and/or hypopnea scored during the course of sleep study
Time Frame
Pre to post treatment (approximately 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Berry, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Sleep Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea

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