Airway Muscle Training for Obstructive Sleep Apnea

Completed · Not applicable · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

The purpose of this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of their apnea. After this study, subjects will be randomly assigned to one of two groups. The first group will receiving a breathing trainer that may strengthen the muscles used to breath in and out. The second group will be receive a sham trainer which looks like the "real" trainer but is not able to produce a strengthening effect. Both groups will complete eight weeks of home based (real or sham) training. The sleep study will be repeated and we well measure any changes in measures of severity for obstructive sleep apnea.

Key facts

Study ID

NCT02259660

Run by

University of Florida

People needed

47

Starts

2015-04-01

Expected to finish

2017-09-28

Last updated by the study team

2018-04-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years,
• AHI ≥ 5/hour and less than 30/hour
• Ability to understand and perform training.
• Ability to return to the UFHealth 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 > 35 kg/M2
• 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.10. severe daytime sleepiness (falling asleep while driving or
• Epworth Sleepiness Scale [Appendix 1] > 14),
• History of chronic short sleep duration (< 5 hours).

Where it is running

• UFHealth Sleep Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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