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

NCT01369576 | Completed Phase 3 DMC

• 1 other identifier: OSRM-0511
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 4

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• CPAP adherence

  6 months

Secondary Outcomes (1)

• ESS and SAQLI scores, changes from baseline, % time of average CPAP usage over the last month/ self-estimated total sleep time (h). Residual AHI monitored, analysed for similar findings at trial closure and analysis, but is not an efficacy parameter

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

zopiclone

EXPERIMENTAL

Sleep apnea OSR Medical Treatment plan ©

Drug: Zopiclone

Interventions

Placebo DRUG

3.75-7.5mg 14 doses 4 weeks

Placebo

Zopiclone DRUG

3.75-7.5mg 14 doses 4 weeks

zopiclone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• OSR Medical Inc.: lead

Study Sites (4)

Cite de la Sante

Laval, Quebec, H7M 3L9, Canada

Location

Institut de medecine specialisee de Laval

Laval, Quebec, H7S 2M5, Canada

Location

Institut de Medecine du sommeil

Montreal, Quebec, H4N 1C5, Canada

Location

Mount Sinai Hospital

Montreal, Quebec, H4W 1S7, Canada

Location

Related Publications (5)

• 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.

  PMID: 18949106 BACKGROUND

• 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.

  PMID: 18250209 BACKGROUND

• 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.

  PMID: 19370691 BACKGROUND

• 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.

  PMID: 19920270 BACKGROUND

• 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.

  PMID: 19567493 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

zopiclone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Paul Verschelden, MD DABSM

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

  PRINCIPAL INVESTIGATOR

• Marcel Baltzan, MDCM DABSM

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

  PRINCIPAL INVESTIGATOR

• Kateri Champagne, MD DABSM

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

  PRINCIPAL INVESTIGATOR

• Germaine Tanzimat, RN

  OSR Medical Inc.

  PRINCIPAL INVESTIGATOR

• Barbara Capozzolo, MSc

  OSR Medical Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

CA (4)