Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea
Snoring, Sleep Apnea, Obstructive
About this trial
This is an interventional device feasibility trial for Snoring
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).
Sites / Locations
- University of Florida Sleep Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Group 1 Primary Snoring Treatment
Group 2 Primary Snoring Placebo
Group 3 Primary OSA Treatment
Group 4 Primary OSA Placebo
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.