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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
2
Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes
Grenoble, France
Average use of the Adapative Servo Ventilation device per day assessed by the device data
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
Time frame: one month
Average use of the Adapative Servo Ventilation device per day assessed by the device data
Time frame: 3 months and 12 months
Residual Apnea, Hypopnea Index (number/hour)
Index assessed by device data
Time frame: 12 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 1 month
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 3 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 12 month
Asthenia assessed by Pichot scale
Time frame: 1 month
Asthenia assessed by Pichot scale
Time frame: 3 months
Asthenia assessed by Pichot scale
Time frame: 12 months
Changes in New York Heart Association score
Time frame: 1 month
Changes in New York Heart Association score
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Time frame: 3 months
Changes in New York Heart Association score
Time frame: 12 months
Number of prescription of hypnotics drug
Time frame: 12 months