Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance (ZODIAC)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Terminated

Phase 4

Conditions

Ventricular Dysfunction

Sleep Apnea, Central

Treatments

Drug: Placebo

Drug: Zopiclone

Study type

Interventional

Funder types

Other

Identifiers

NCT02820441

38RC15.175

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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