Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
OSR Medical Inc.
ClinicalTrials.gov Identifier:
NCT01369576
First received: June 7, 2011
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Drug: Placebo
Drug: Zopiclone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by OSR Medical Inc.:

Primary Outcome Measures:
  • CPAP adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Usual sleep apnea and CPAP care Sleep apnea OSR Medical Treatment Plan©
Drug: Placebo
3.75-7.5mg 14 doses 4 weeks
Other Name: Placebo
Experimental: zopiclone
Sleep apnea OSR Medical Treatment plan ©
Drug: Zopiclone
3.75-7.5mg 14 doses 4 weeks
Other Name: Zopiclone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369576

Locations
Canada, Quebec
Cite de la Sante
Laval, Quebec, Canada, H7M 3L9
Institut de medecine specialisee de Laval
Laval, Quebec, Canada, H7S 2M5
Institut de Medecine du sommeil
Montreal, Quebec, Canada, H4N 1C5
Mount Sinai Hospital
Montreal, Quebec, Canada, H4W 1S7
Sponsors and Collaborators
OSR Medical Inc.
Investigators
Principal Investigator: 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.
  More Information

Publications:
Responsible Party: OSR Medical Inc.
ClinicalTrials.gov Identifier: NCT01369576     History of Changes
Other Study ID Numbers: OSRM-0511
Study First Received: June 7, 2011
Last Updated: May 7, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Zopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014