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

ISRCTN	ISRCTN80924721
DOI	https://doi.org/10.1186/ISRCTN80924721
Protocol serial number	N/A
Sponsor	McGill University Health Centre Research Institute (Canada)
Funders	Operating funds provided by the Sponsor: MUHC Research Institute (Canada), Study drug, but no operating or other funds provided by Abbott Laboratories (Canada)

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

Dr Richard John Kimoff
Scientific

McGill University Health Centre
Room L4.08
687 Pine Ave W
Montreal, Quebec
H3A 1A1
Canada

Phone	+1 514-934-1934, ext. 36117
Email	john.kimoff@muhc.mcgill.ca

Primary study design	Interventional
Study design	Randomised, controlled trial, single-blinded: drug versus no-drug.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lansoprazole
Primary outcome measure(s)	Change in apnea-hypopnea index from baseline to six months.
Key secondary outcome measure(s)	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.
Completion date	31/10/2007

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	44
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

McGill University Health Centre

Montreal, Quebec
H3A 1A1
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan