Effects of Upper Airway Muscle Training on OSA
Obstructive Sleep Apnea
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Exercise, Upper airway muscle
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Untreated OSA Muscle Exercise Group
PAP Therapy Muscle Exercise Group
Oral Appliance Muscle Exercise Group
Normal Control Sham Exercise Group
Patients who were previously diagnosed of obstructive sleep apnea (OSA) with apnea hypopnea index (AHI) > 10 events/hr and have previously failed or refused PAP therapy. In this group, patients will learn and practice upper airway muscle exercise for six weeks.
OSA patients who are currently treated with PAP for their OSA (with AHI of previous sleep study > 10 events/hr). In this group, patients will learn and practice upper airway muscle exercise for six weeks.
OSA patients who are currently treated with an oral appliance with residual AHI > 10 events/hr. In this group, patients will learn and practice upper airway muscle exercise for six weeks.
Patients of untreated OSA group, PAP therapy group, and oral appliance group are randomized to upper airway muscle exercise versus sham exercise.