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

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

Interventions

DRUG

Placebo

3.75-7.5mg 14 doses 4 weeks

DRUG

Zopiclone

3.75-7.5mg 14 doses 4 weeks

Sponsors & Collaborators

• OSR Medical Inc.

  lead INDUSTRY

Principal Investigators

• Paul Verschelden, MD DABSM · Cite de la Sante, University of Montreal, OSR Medical, Institut de medecine specialisee de Laval (IMSL)

• Marcel Baltzan, MDCM DABSM · McGill University, OSR Medical, Institut de medecine du sommeil (IMS)

• Kateri Champagne, MD DABSM · McGill University Health Centre (MUHC), OSR Medical, Institut de medecine du sommeil (IMS)

• Germaine Tanzimat, RN · OSR Medical Inc.

• Barbara Capozzolo, MSc · OSR Medical Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2014-05-31

Completion

2014-11-30

Countries

• Canada

Study Locations