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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOPICLONE | Experimental | Zopiclone 3.5 mg capsule by mouth daily for 2 weeks |
|
| PLACEBO | Placebo Comparator | Placebo 3.5 mg capsule by mouth daily for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zopiclone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Average use of the Adapative Servo Ventilation device per day assessed by the device data | 3 months and 12 months | |
| Residual Apnea, Hypopnea Index (number/hour) | Index assessed by device data | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie DESTORS, MD | University Hospital, Grenoble Alpes, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25539680 | Background | Boccon-Gibod I, Bouillet L. [Angioedema and urticaria]. Ann Dermatol Venereol. 2014 Nov;141 Suppl 3:S586-95. doi: 10.1016/S0151-9638(14)70162-0. French. | |
| 25511651 | Background | Pagnier A. [Hereditary angioedema in childhood. Diagnosis and therapeutic challenges]. Presse Med. 2015 Jan;44(1):89-95. doi: 10.1016/j.lpm.2014.07.018. Epub 2014 Dec 12. French. |
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| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| D018754 | Ventricular Dysfunction |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C515050 | zopiclone |
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| Drug |
|
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 1 month |
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 3 months |
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 12 month |
| Asthenia assessed by Pichot scale | 1 month |
| Asthenia assessed by Pichot scale | 3 months |
| Asthenia assessed by Pichot scale | 12 months |
| Changes in New York Heart Association score | 1 month |
| Changes in New York Heart Association score | 3 months |
| Changes in New York Heart Association score | 12 months |
| Number of prescription of hypnotics drug | 12 months |
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| Background | Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins. |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |