Effects of proton pump inhibitor treatment on apnea severity in patients with laryngopharyngeal reflux and obstructive sleep apnea
ISRCTN | ISRCTN80924721 |
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DOI | https://doi.org/10.1186/ISRCTN80924721 |
Secondary identifying numbers | N/A |
- Submission date
- 25/10/2006
- Registration date
- 05/01/2007
- Last edited
- 05/01/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard John Kimoff
Scientific
Scientific
McGill University Health Centre
Room L4.08
687 Pine Ave W
Montreal, Quebec
H3A 1A1
Canada
Phone | +1 514-934-1934, ext. 36117 |
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john.kimoff@muhc.mcgill.ca |
Study information
Study design | Randomised, controlled trial, single-blinded: drug versus no-drug. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | In patients with mild to moderate Obstructive Sleep Apnea (OSA) and endoscopic evidence of laryngeal inflammation, proton pump inhibitor treatment will lead to an improvement in apnea severity and apnea-related symptoms. |
Ethics approval(s) | McGill University Health Centre Research Ethics Board (Study No. BMA 05-018), approved January 24, 2006. |
Health condition(s) or problem(s) studied | Obstructive Sleep Apnea |
Intervention | Six month treatment with Lansoprazole 30 mg orally twice a day (BID) or no drug. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Lansoprazole |
Primary outcome measure | Change in apnea-hypopnea index from baseline to six months. |
Secondary outcome measures | 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. |
Overall study start date | 01/11/2006 |
Completion date | 31/10/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 44 (22 per group) |
Key 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 |
Key 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 |
Date of first enrolment | 01/11/2006 |
Date of final enrolment | 31/10/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
McGill University Health Centre
Montreal, Quebec
H3A 1A1
Canada
H3A 1A1
Canada
Sponsor information
McGill University Health Centre Research Institute (Canada)
Hospital/treatment centre
Hospital/treatment centre
1650 Cedar Ave
Room A6.141
Montreal, Quebec
H3G 1A4
Canada
Phone | +1 514-934-1934 ext. 44580 |
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lynn.derycapes@muhc.mcgill.ca | |
Website | http://www.muhc.ca/research |
https://ror.org/04cpxjv19 |
Funders
Funder type
Hospital/treatment centre
Operating funds provided by the Sponsor: MUHC Research Institute (Canada)
No information available
Study drug, but no operating or other funds provided by Abbott Laboratories (Canada)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |