Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea

NCT ID: NCT01369576

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-11-30

Brief Summary

The clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia. Outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent trial of eszopiclone. This size is expected to be able to discern an important difference of 80 minutes per night. In the current clinical population newly prescribed CPAP at Mount Sinai Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD 2:59) hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in usage per night, including entirely non-adherent patients who do not use treatment at all as 'zero hour' users, would require randomization of 264 patients (132 per group).

Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be improved by initial prescription of a common hypnotic, zopiclone. To answer this question we intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician (ABSM or by a respirologist with extensive sleep medicine experience) with supportive polysomnography results who are willing to initiate long-term CPAP treatment.

Detailed Description

Background: Obstructive sleep apnea (OSA) is a common sleep breathing disorder that is associated with serious complications. Continuous positive airway pressure (CPAP) is the treatment of choice for most patients but its use in the real world is limited by low patient adherence which may result in sub-optimal outcomes for some patients. A single hypnotic with low risk of adverse effects is a cost-effective intervention to augment the currently low adherence to CPAP, especially if only prescribed for a limited time. The hypnotic is generic zopiclone 3.75-7.5 mg at bedtime for up to 14 doses.

The clinical population targeted will be newly expert physician-diagnosed patients polysomnographically supported OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia. Outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Usual sleep apnea and CPAP care Sleep apnea OSR Medical Treatment Plan©

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3.75-7.5mg 14 doses 4 weeks

zopiclone

Sleep apnea OSR Medical Treatment plan ©

Group Type: EXPERIMENTAL

Zopiclone

Intervention Type: DRUG

3.75-7.5mg 14 doses 4 weeks

Interventions

Placebo

3.75-7.5mg 14 doses 4 weeks

Intervention Type: DRUG

Zopiclone

3.75-7.5mg 14 doses 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• MD diagnosis of obstructive sleep apnea
• No previous use of CPAP
• No concurrent use of hypnotic medication

Exclusion Criteria

• Fatal comorbidities (i.e., life expectancy less than 6 months)
• Contraindications for CPAP use
• Pregnancy
• Liver Failure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSR Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Verschelden, MD DABSM

Role: PRINCIPAL_INVESTIGATOR

Cite de la Sante, University of Montreal, OSR Medical, Institut de medecine specialisee de Laval (IMSL)

Marcel Baltzan, MDCM DABSM

Role: PRINCIPAL_INVESTIGATOR

McGill University, OSR Medical, Institut de medecine du sommeil (IMS)

Kateri Champagne, MD DABSM

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre (MUHC), OSR Medical, Institut de medecine du sommeil (IMS)

Germaine Tanzimat, RN

Role: PRINCIPAL_INVESTIGATOR

OSR Medical Inc.

Barbara Capozzolo, MSc

Role: PRINCIPAL_INVESTIGATOR

OSR Medical Inc.

Locations

Cite de la Sante

Laval, Quebec, Canada

Institut de medecine specialisee de Laval

Laval, Quebec, Canada

Institut de Medecine du sommeil

Montreal, Quebec, Canada

Mount Sinai Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Wolkove N, Baltzan M, Kamel H, Dabrusin R, Palayew M. Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea. Can Respir J. 2008 Oct;15(7):365-9. doi: 10.1155/2008/534372.

Reference Type: BACKGROUND

PMID: 18949106 (View on PubMed)

Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.

Reference Type: BACKGROUND

PMID: 18250209 (View on PubMed)

Smith I, Nadig V, Lasserson TJ. Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines for adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007736. doi: 10.1002/14651858.CD007736.

Reference Type: BACKGROUND

PMID: 19370691 (View on PubMed)

Lettieri CJ, Shah AA, Holley AB, Kelly WF, Chang AS, Roop SA; CPAP Promotion and Prognosis-The Army Sleep Apnea Program Trial. Effects of a short course of eszopiclone on continuous positive airway pressure adherence: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):696-702. doi: 10.7326/0003-4819-151-10-200911170-00006.

Reference Type: BACKGROUND

PMID: 19920270 (View on PubMed)

Lettieri CJ, Collen JF, Eliasson AH, Quast TM. Sedative use during continuous positive airway pressure titration improves subsequent compliance: a randomized, double-blind, placebo-controlled trial. Chest. 2009 Nov;136(5):1263-1268. doi: 10.1378/chest.09-0811. Epub 2009 Jun 30.

Reference Type: BACKGROUND

PMID: 19567493 (View on PubMed)

Other Identifiers

OSRM-0511

Identifier Type: -

Identifier Source: org_study_id