Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.