Contact information
Type
Scientific
Primary contact
Dr Richard John Kimoff
ORCID ID
Contact details
McGill University Health Centre
Room L4.08
687 Pine Ave W
Montreal
Quebec
H3A 1A1
Canada
+1 514-934-1934, ext. 36117
john.kimoff@muhc.mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
McGill University Health Centre Research Ethics Board (Study No. BMA 05-018), approved January 24, 2006.
Study design
Randomised, controlled trial, single-blinded: drug versus no-drug.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Lansoprazole
Primary outcome measures
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 trial start date
01/11/2006
Overall trial end date
31/10/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
44 (22 per group)
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
31/10/2007
Locations
Countries of recruitment
Canada
Trial participating centre
McGill University Health Centre
Montreal, Quebec
H3A 1A1
Canada
Sponsor information
Organisation
McGill University Health Centre Research Institute (Canada)
Sponsor details
1650 Cedar Ave
Room A6.141
Montreal
Quebec
H3G 1A4
Canada
+1 514-934-1934 ext. 44580
lynn.derycapes@muhc.mcgill.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Operating funds provided by the Sponsor: MUHC Research Institute (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Study drug, but no operating or other funds provided by Abbott Laboratories (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary