Obstructive Sleep ApneaPhase 3NCT01369576
Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
A Phase 3 study testing Zopiclone in people with Obstructive Sleep Apnea, run by OSR Medical Inc. at 4 sites in Canada.
Trial summary
The clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Zopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 4 sitesCanada
- Study dates
- May 2011to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MD diagnosis of obstructive sleep apnea
- No previous use of CPAP
- No concurrent use of hypnotic medication
Who cannot join
- Fatal comorbidities (i.e., life expectancy less than 6 months)
- Contraindications for CPAP use
- Pregnancy
- Liver Failure
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Cite de la Sante
Laval, Quebec, H7M 3L9
Institut de medecine specialisee de Laval
Laval, Quebec, H7S 2M5
Institut de Medecine du sommeil
Montreal, Quebec, H4N 1C5
Mount Sinai Hospital
Montreal, Quebec, H4W 1S7
About this study
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
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.
Read the 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
- Being tested
- Placebo, Zopiclone
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
3.75-7.5mg 14 doses 4 weeks
ZopicloneDrug
3.75-7.5mg 14 doses 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Usual sleep apnea and CPAP care Sleep apnea OSR Medical Treatment Plan© Receives: Drug: Placebo |
| zopiclone | Experimental | Sleep apnea OSR Medical Treatment plan © Receives: Drug: Zopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSR Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Verschelden, MD DABSM, Principal investigator, Cite de la Sante, University of Montreal, OSR Medical, Institut de medecine specialisee de Laval (IMSL)Marcel Baltzan, MDCM DABSM, Principal investigator, McGill University, OSR Medical, Institut de medecine du sommeil (IMS)Kateri Champagne, MD DABSM, Principal investigator, McGill University Health Centre (MUHC), OSR Medical, Institut de medecine du sommeil (IMS)Germaine Tanzimat, RN, Principal investigator, OSR Medical Inc.Barbara Capozzolo, MSc, Principal investigator, OSR Medical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369576
- Sponsor's protocol ID
- OSRM-0511
- Status last verified
- Jul 2015
- First submitted
- 7 Jun 2011
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18949106Weaver 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.
PubMed 18250209Smith 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.
PubMed 19370691Lettieri 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.
PubMed 19920270Lettieri 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.
PubMed 19567493
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01369576
- Acronym / sponsor ID
- OSRM-0511
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- OSR Medical Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboUsual sleep apnea and CPAP care Sleep apnea OSR Medical Treatment Plan© |
| zopiclone | Experimental | Drug: ZopicloneSleep apnea OSR Medical Treatment plan © |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MD diagnosis of obstructive sleep apnea
- No previous use of CPAP
- No concurrent use of hypnotic medication
Key exclusion criteria (4 listed)
- Fatal comorbidities (i.e., life expectancy less than 6 months)
- Contraindications for CPAP use
- Pregnancy
- Liver Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo3.75-7.5mg 14 doses 4 weeks | Drug | Placebo |
| Zopiclone3.75-7.5mg 14 doses 4 weeks | Drug | zopiclone |
Primary outcome
CPAP adherence
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Background: PubMed 18949106Wolkove 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.
- Background: PubMed 18250209Weaver 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.
- Background: PubMed 19370691Smith 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.
- Background: PubMed 19920270Lettieri 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.
- Background: PubMed 19567493Lettieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Verschelden, MD DABSM principal investigator
Cite de la Sante, University of Montreal, OSR Medical, Institut de medecine specialisee de Laval (IMSL)
Marcel Baltzan, MDCM DABSM principal investigator
McGill University, OSR Medical, Institut de medecine du sommeil (IMS)
Kateri Champagne, MD DABSM principal investigator
McGill University Health Centre (MUHC), OSR Medical, Institut de medecine du sommeil (IMS)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zopiclone in people with Obstructive Sleep Apnea, run by OSR Medical Inc. at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01369576, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.