Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep efficiency
研究概览
简要总结
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug (zolpidem controlled release).
The study hypothesis is that sleeping better can improve the heart recovery in patients with a diagnosis of acute coronary syndrome.
详细描述
The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.
The objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes [troponin T and creatine kinase MB (CK-MB)] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 18 to 75 years of age
- •Diagnosis of acute coronary syndrome
- •Capable of swallowing pills
- •Capable of filling in the questionaires
排除标准
- •Class IV heart failure according to the New York heart association functional class,
- •Patients in a coma
- •Patients receiving mechanical ventilation
- •Patients who regularly use benzodiazepines or other medications for inducing sleep
研究组 & 干预措施
Zolpidem CR 12.5mg
Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
干预措施: Zolpidem CR 12.5mg (Drug)
Placebo
Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep efficiency
时间窗: 1 day - the first night
A full-night polysomnography is conducted in the first night on the ICU
次要结局
- Troponin T(Within the first 3 days after an acute coronary syndrome diagnosis)
- Creatine-kinase MB(Within the first 3 days after an acute coronary syndrome diagnosis)
研究者
Patrick Rademaker Burke
Sleep Medicine PhD Student
Associação Fundo de Incentivo à Pesquisa