Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- EEG Slow Wave Activity During Sleep
研究概览
简要总结
The investigators wish to investigate whether enhancement of SWS, which is seen after a drug called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function, specifically sleepiness and mental performance. This is a safe and well-tolerated drug that is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.
The investigators will study 12 patients diagnosed with CFS using international diagnostic guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be taken nightly, and the investigators will measure next-day sleepiness, mental performance and fatigue, and compare drug and placebo nights.
详细描述
Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment and other symptoms, is associated with neither a currently identifiable disease process nor major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep impairment is common in nearly everyone with CFS, with both daytime sleepiness and unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be that fundamental regulatory processes that control sleep are disturbed in CFS, leading to different effects on sleep and daytime symptoms depending on the subject's prior sleep, daytime routine, medication and other factors. The investigators contacts with patient groups have indicated that patients are generally confident that on days when their sleep is better they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sodium oxybate first, then placebo
Subjects received a single dose of sodium oxybate (3.0g as liquid) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of placebo comparator (fresh potable water) at bedtime for 4 nights
干预措施: Sodium Oxybate (Drug)
Placebo first, then sodium oxybate
Subjects received a single dose of placebo comparator (fresh potable water) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of sodium oxybate (3.0g as liquid) at bedtime for 4 nights
干预措施: Sodium Oxybate (Drug)
Placebo first, then sodium oxybate
Subjects received a single dose of placebo comparator (fresh potable water) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of sodium oxybate (3.0g as liquid) at bedtime for 4 nights
干预措施: placebo (fresh potable water) (Other)
Sodium oxybate first, then placebo
Subjects received a single dose of sodium oxybate (3.0g as liquid) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of placebo comparator (fresh potable water) at bedtime for 4 nights
干预措施: placebo (fresh potable water) (Other)
结局指标
主要结局
EEG Slow Wave Activity During Sleep
时间窗: night 4
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\^2/Hz)
Daytime Sleepiness
时间窗: Day 5
time to fall asleep in minutes
次要结局
未报告次要终点