Effects of Upper Airway Muscle Training on OSA

Completed · Not applicable · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep. OSA patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse. Previous studies of upper airway muscle training showed variable results on OSA, but so far there has not been any practical, long-term, systematic upper airway muscle training developed or studied as the treatment of OSA. In theory, strengthening the upper airway muscle with exercise training in theory helps maintain a patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle training can improve sleep apnea in some patients with OSA, including those already receiving treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a definable subset of OSA patients. Investigators hypothesize that patients with OSA who have mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a positive association between the changes in muscle function and improvement in OSA severity.

Key facts

Study ID

NCT02502942

Run by

University of California, San Diego

People needed

134

Starts

2015-08-01

Expected to finish

2019-06-24

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior diagnosis of OSA with AHI>10 events/hr.
• PAP group: subjects who have been on PAP treatment for at least 3 month, with good compliance (at least 4 hours a day and use PAP for >70% of the time).
• Untreated group: untreated subjects with generally mild OSA as defined by AHI<20 events/hr and nadir SaO2>70%. Additionally, investigators will also recruit OSA subjects of all severities who have previously tried but are not currently using PAP.
• Oral appliance treatment group: subjects have residual AHI >10 events/hr with oral appliance therapy.

You may not qualify if…

• In those with untreated sleep apnea, severe sleepiness with current Epworth Sleepiness Scale (ESS) > 18 or history of motor vehicle accident due to obstructive sleep apnea
• Taking medications classified as a muscle relaxant
• Pregnant women.
• Psychiatric disorder, other than mild and controlled depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
• Current smokers, alcohol (>3oz/day) or use of illicit drugs.
• More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
• Unstable cardiac disease (e.g. congestive heart failure)
• Pulmonary disease (apart from well controlled mild asthma and OSA)
• Systemic neuromuscular disease
• Other systemic disease that affects breathing (e.g. stroke) or those with expected survival < 1 year.
• Poor oral condition, including: active periodontal disease, loose or broken teeth, lack of eight teeth in each arch, active TMJ dysfunction
• Known allergy to oral appliance components

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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