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