NCT02820441

Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Apnea, Central
• Ventricular Dysfunction

Interventions

Type	Name	Description
DRUG	Zopiclone
DRUG	Placebo

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-09-01
• Completion: 2018-06-01
• First posted: 2016-07-01
• Last updated: 2021-05-26

Locations

1 site across 1 country: France