Improving Sleep Quality in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Sleep Latency
研究概览
简要总结
Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. However, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. The nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. The investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-79 years old
- •HFrEF, EF ≤ 45% (by echocardiography)
- •NYHA functional class I to III
- •Able to give written consent
- •On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment
- •No hospitalizations for HF within the past month
- •Positive response to experiencing any of the following sleep-related symptoms at least once a week:
- •Difficulty falling asleep
- •Waking up during the night and having difficulty getting back to sleep
- •Waking up too early in the morning and being unable to get back to sleep.
排除标准
- •Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks
- •Current treatment with other sedating medications such as opioids
- •On therapy for pharmacological therapy for depression
- •History of alcohol/drug dependence
- •History of liver disease, HIV, or severe COPD
- •On Thorazine
- •Current use of ketoconazole
- •Current use of tricyclic antidepressants
- •Current use of macrolide antibiotics
- •Current use of anticonvulsant medications
- •Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.
研究组 & 干预措施
Intervention
干预措施: Zolpidem Tartrate (Drug)
Control
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Sleep Latency
时间窗: 1 week
Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.
Sleep Efficiency
时间窗: 1 week
Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.
Total Sleep Time
时间窗: 1 week
Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.
次要结局
未报告次要终点