Clinical trial NCT02820441: Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance
Official title: Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sleep Apnea, Central
Ventricular Dysfunction
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Average use of the Adapative Servo Ventilation device per day assessed by the device data
timeFrame: one month
Secondary outcomes:
measure: Average use of the Adapative Servo Ventilation device per day assessed by the device data
timeFrame: 3 months and 12 months
measure: Residual Apnea, Hypopnea Index (number/hour)
timeFrame: 12 months
measure: Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: 1 month
measure: Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: 3 months
measure: Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: 12 month
measure: Asthenia assessed by Pichot scale
timeFrame: 1 month
measure: Asthenia assessed by Pichot scale
timeFrame: 3 months
measure: Asthenia assessed by Pichot scale
timeFrame: 12 months
measure: Changes in New York Heart Association score
timeFrame: 1 month
measure: Changes in New York Heart Association score
timeFrame: 3 months
measure: Changes in New York Heart Association score
timeFrame: 12 months
measure: Number of prescription of hypnotics drug
timeFrame: 12 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble Alpes, FRANCE
name: Marie DESTORS, MD
role: PRINCIPAL_INVESTIGATOR
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