Condition category
Musculoskeletal Diseases
Date applied
25/10/2006
Date assigned
05/01/2007
Last edited
05/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.muhc.ca/research

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

Publication citations

Additional files

Editorial Notes