Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

Phase 4

Terminated

• Conditions: Ventricular Dysfunction; Sleep Apnea, Central
• Interventions: Drug: Placebo; Drug: Zopiclone

• Registration Number: NCT02820441
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-07-01
• Primary Completion: 2017-09
• Study Completion: 2018-06
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	Placebo	Placebo 3.5 mg capsule by mouth daily for 2 weeks
ZOPICLONE	Zopiclone	Zopiclone 3.5 mg capsule by mouth daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Average use of the Adapative Servo Ventilation device per day assessed by the device data	one month	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes; 🇫🇷 Grenoble, France