Obstructive Sleep Apnea Musculoskeletal Diseases Involuntary closing of the muscles of the throat
Conditions
Interventions
Six month treatment with Lansoprazole 30 mg orally twice a day (BID) or no drug.
Sponsors
McGill University Health Centre Research Institute (Canada)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults 20 to 70 years with untreated obstructive sleep apnea, non-smoking 2. Epworth sleepiness score less than 15 3. Apnea-hypopnea index of 15 to 60 events per hour, with Non-Rapid Eye Movement Apnea Hypopnea Index (NREM AHI) more than 10, nadir Saturation of Oxygen in arterial blood (SaO2) more than or equal to 80% at overnight polysomnography 4. Reflux Finding Score more than 7 on laryngoscopy
Exclusion criteria
Exclusion criteria: 1. Any prior treatment for OSA 2. Current or past proton pump inhibitor therapy, current inhaled or systemic corticosteroid, or systemic immunosuppressive treatment 3. Active cardiovascular disease (uncontrolled hypertension, unstable angina, myocardial infarction within the preceding six months, congestive heart failure) 4. Epworth Sleepiness Score more than 15 or employment in a safety critical position regardless of Epworth Score 5. History of a bleeding disorder 6. Otolaryngologic conditions including glottic or subglottic stenosis, cancer of the larynx, previous radiotherapy, upper airway surgery other than remote tonsillectomy, or major craniofacial malformation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in apnea-hypopnea index from baseline to six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Laryngoscopic Reflux Finding Score 2. Laryngeal air pressure pulse sensory threshold 3. Reflux Symptom Index 4. Epworth Sleepiness Score 5. Quebec Sleep Apnea Quality of Life Index 6. Functional Outcomes of Sleep instrument All at baseline, four and six months; also Polysomnographic variables other than apnea-hypopnea Index at baseline and six months. | — |
Countries
Canada
Outcome results
None listed