Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- transcutaneous PCO2
研究概览
简要总结
The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease.
The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.
详细描述
Rationale: More than 50% of patients with chronic obstructive pulmonary disease (COPD) have sleep complaints characterised by longer latency to falling asleep, more frequent arousals and awakenings, generalised insomnia and/or excessive daytime sleepiness. Sleep disturbance seems to be more severe with advancing disease and substantially reduces patients' quality of life. The sleep complaints are due to dyspnea, chronic cough, sputum production, hypoxaemia and hypercapnia during the night. One of the available therapies for these patients is the prescription of hypnotics (like benzodiazepines). However, it is thought that in patients with COPD sleep medication may produce adverse respiratory effects due to suppression of the cerebral respiratory drive. In our practice, we never encounter any adverse respiratory effect of an hypnotic in patients with COPD. There have been several trials in COPD patients studying these potentially adverse effects. The results of these studies are inconsistent, relative older hypnotics are used and there are several methodological limitations. Furthermore, in none of these studies transcutaneous PCO2 or PO2 was monitored. Temazepam is nowadays the sedative of first choice in the medical treatment of sleep complaints.
Aim: primary: studying the effects of temazepam on the respiratory function during daytime and at night in patients with severe COPD. Secondary: studying the effects of temazepam on the sleep quality and sleep structure and on the objective and subjective sleepiness during daytime and at night in patients with COPD.
Study design: double blind, placebo-controlled, cross-over randomised clinical trial.
Treatment: 10 mg temazepam or placebo during seven consecutive nights.
Endpoints: Primary: difference in PtcCO2, PtcO2 and oxygen saturation during sleep after 1 week temazepam compared to placebo. Secondary: Respiratory Disturbance Index, Desaturation Index and Hypercapnic Ventilatory Response, percentage REM/nREM-sleep and total effective sleep time, Multiple Sleep Latency Test and the Epworth Sleeping Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of COPD, GOLD 3 or 4
- •having subjective sleeping problems
- •longer latency to falling asleep
- •frequent arousals
- •excessive daytime sleepiness
- •clinical stable health for minimally 6 weeks
排除标准
- •usage of some sort of medication that influences sleep in any kind of way (like benzodiazepines, barbiturates, opiates, amfetamines) which can not be discontinued during the study period
- •alcohol abuse
- •hospitalisation 6 weeks or shorter before enrollment in the study
- •hyperreactivity / allergy to benzodiazepines
- •history of benzodiazepine-dependence
- •myasthenia gravis
- •obstructive sleep apnea syndrome (OSAS)
- •severe liver failure
- •age under 18 years
- •participation in another study less than 6 weeks before enrollment
- •COPD exacerbation less than 6 weeks before enrollment
- •usage of oxygen supplementation at home
结局指标
主要结局
transcutaneous PCO2
transcutaneous PO2
Oxygen saturation
次要结局
- Hypercapnic Ventilatory Response
- total sleeping time
- sleep latency
- Respiratory Disturbance Index
- Desaturation Index
- MSLT
- arterial PO2
- arterial PCO2
- percentage REM- and nREM-sleep of total sleep time
- number of arousals
- number of apneas during sleep
- number of hypopneas during sleep
- Epworth Sleeping Score
- Dyspnea Visual Analog Score