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NCT Number: NCT01369576

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cite de la Sante, Laval, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

3.75-7.5mg 14 doses 4 weeks

Zopiclone

Drug

3.75-7.5mg 14 doses 4 weeks

Primary outcomes

  1. CPAP adherence

    Time frame: 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

OSR Medical Inc.

Industry

Registry information

Official study title

A Double-blind, Randomized, Parallel Group Study to Determine the Effect of Initial Prescription of Zopiclone on the Level of Compliance With CPAP in Adult Patients Treated for OSA at 26 Weeks

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2011
Registry last updated
Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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