Overview

Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

Status:
Terminated
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Grenoble
Treatments:
Zopiclone
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