A Phase 4 interventional study of Zopiclone and Placebo in Sleep Apnea, Central and Ventricular Dysfunction, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by University Hospital, Grenoble · Phase 4, Interventional, and Supportive care
The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with 14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.
ASV remain the optimal treatment for CSA in Heart Failure patients with preserved left ventricular ejection fraction (LVEF).
Yet, the adaptation to the ventilation is extremely challenging and the resulting difficulties encountered to sleep induction might be a reason for dropping out.
Zopiclone is indicated for the short-term treatment of insomnia where sleep initiation or sleep maintenance are prominent symptoms. In this study, Zopiclone, as sedative and hypnotic agent, is used during the ASV initiation period.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 2 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Zopiclone 3.5 mg capsule by mouth daily for 2 weeks
Drug: Zopiclone
Placebo 3.5 mg capsule by mouth daily for 2 weeks
Drug: Placebo
Also known as: IMOVANE
Average use of the Adapative Servo Ventilation device per day assessed by the device data
daily use of the device (hours/day, mean value), amount of hours and number of day the device has been used as assessed by the device data
Time frame: one month
Average use of the Adapative Servo Ventilation device per day assessed by the device data
Time frame: 3 months and 12 months
Residual Apnea, Hypopnea Index (number/hour)
Index assessed by device data
Time frame: 12 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 1 month
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 3 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 12 month
Asthenia assessed by Pichot scale
Time frame: 1 month
Asthenia assessed by Pichot scale
Time frame: 3 months
Asthenia assessed by Pichot scale
Time frame: 12 months
Changes in New York Heart Association score
Time frame: 1 month
Changes in New York Heart Association score
Time frame: 3 months
Changes in New York Heart Association score
Time frame: 12 months
Number of prescription of hypnotics drug
Time frame: 12 months
Plan to share: No
This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble