Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Sleep Apnea, Central, Ventricular Dysfunction

Intervention / Treatment
-----------------
* Drug: Zopiclone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged between 18 and 90 years at the initial visit Central Sleep Apnea with an AHI ≥ 15/h and at least 50% of central events indicating an ASV therapy, as determined by a ventilatory polygraphy (PG) or a polysomnography (PSG) Cardiac Dysfunction with Left Ventricular Ejection fraction(LVEF)> 45% determined by a transthoracic echocardiography (TTE), known for more than 12 weeks and stable for at least 4 weeks; Compliance less than 3 hours after 7 days of the setting up of ASV; Patient affiliated to a social security scheme or being beneficiary of such scheme; Patient voluntarily participating in the research, with written informed consent Exclusion Criteria: Current use of continuous positive airway pressure (cPAP) for treatment of sleep apnea during the last 12 months Presence of chronic symptomatic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 45%), and a CSA moderate to severe (AHI ≥15 / h) Presence of severe pulmonary bullous disease Presence of Pneumothorax or pneumomediastinum Hypotension, especially if associated with depletion of intravascular volume Dehydration Leaking of cerebrospinal fluid, cranial surgery or trauma recently. Episode of acute respiratory failure or heart failure in the previous month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOPICLONE<br>Zopiclone 3.5 mg capsule by mouth daily for 2 weeks | Drug: Zopiclone<br> <br> * Other names: IMOVANE;|
| Placebo Comparator: PLACEBO<br>Placebo 3.5 mg capsule by mouth daily for 2 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average use of the Adapative Servo Ventilation device per day assessed by the device data |  | 3 months and 12 months | 
| Residual Apnea, Hypopnea Index (number/hour) | Index assessed by device data | 12 months | 
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) |  | 1 month | 
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) |  | 3 months | 
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) |  | 12 month | 
| Asthenia assessed by Pichot scale |  | 1 month | 
| Asthenia assessed by Pichot scale |  | 3 months | 
| Asthenia assessed by Pichot scale |  | 12 months | 
| Changes in New York Heart Association score |  | 1 month | 
| Changes in New York Heart Association score |  | 3 months | 
| Changes in New York Heart Association score |  | 12 months | 
| Number of prescription of hypnotics drug |  | 12 months |