Effects of proton pump inhibitor treatment on apnea severity in patients with laryngopharyngeal reflux and obstructive sleep apnea

Completed

Conditions: Obstructive Sleep Apnea
Musculoskeletal Diseases
Involuntary closing of the muscles of the throat

Registration Number: ISRCTN80924721

Lead Sponsor: McGill University Health Centre Research Institute (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in apnea-hypopnea index from baseline to six months.

Secondary Outcome Measures

Name	Time	Method
1. Laryngoscopic Reflux Finding Score<br>2. Laryngeal air pressure pulse sensory threshold<br>3. Reflux Symptom Index<br>4. Epworth Sleepiness Score<br>5. Quebec Sleep Apnea Quality of Life Index<br>6. Functional Outcomes of Sleep instrument <br><br>All at baseline, four and six months; also Polysomnographic variables other than apnea-hypopnea Index at baseline and six months.