Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Average use of the Adapative Servo Ventilation device per day assessed by the device data
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ZOPICLONE
Zopiclone 3.5 mg capsule by mouth daily for 2 weeks
干预措施: Zopiclone (Drug)
PLACEBO
Placebo 3.5 mg capsule by mouth daily for 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Average use of the Adapative Servo Ventilation device per day assessed by the device data
时间窗: 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
次要结局
- Asthenia assessed by Pichot scale(12 months)
- Residual Apnea, Hypopnea Index (number/hour)(12 months)
- 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)