The Effect of Dexmedetomidine on Patients With Chronic Insomnia and Its Influence on Circadian Rhythm:Randomized Clinical Trial, Double Blind
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Sleep efficiency
研究概览
简要总结
It has been reported that dexmedetomidine, alpha-2 adrenoceptor agonist, can activate endogenous neural sleep pathways in the central nervous system. This randomised, double-blinded and controlled trial was designed to investigate whether dexmedetomidine can improve/treat chronic insomnia patients. Its effects on sleep quality and improvement, EEG and circadian rhythm, brain connectivity, cognition and biomarker changes are determined.
详细描述
Insomnia is a common sleep disorder characterized by difficulty in starting or maintaining sleep, or poor sleep quality and shortened sleep time. The prevalence of insomnia is about 10-20% of population worldwide; Of which about approximately 50% are chronic. Insomnia is a risk factor for cognitive impairment and mental disorder development, and other diseases. Non-pharmacological interventions, e.g. physio-therapy, are often ineffective. Benzodiazepines and their derivatives are commonly prescribed for those patients but their side effects and long-time residual sleepy actions are very risky.
Dexmedetomidine is a highly selective α2 adrenergic receptor agonist with sedative, analgesic and anti-anxiety effects together with remarkable cytoprotective effects. It is widely used as a sedative. Dexmedetomidine was reported promote sleep. It can also modulate "clock" protein expression and hence afford a regulatory effects on the circadian rhythm. This randomised, double-blinded and controlled trial was designed to investigate whether dexmedetomidine can treat chronic insomnia patients. Its effects on sleep quality and improvement, EEG and circadian rhythm, brain connectivity, cognition and biomarker changes are determined. All participants are randomly assigned to receive either dexmedetomidine (a 0.5μg/kg bolus injection for 10 minutes followed by 0.1µg/kg/hr) or placebo (normal saline infusion with an identical protocol as Dex) for 8 hrs from 10pm to 6 am.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18- 65 years old
- •Body mass index (BMI) between 18 and 35 kg/m^2;
- •Clinical diagnosis of chronic insomnia;
- •Must be able to communicate with site personnel
排除标准
- •Clinical diagnosis of mental disorders;
- •Pregnancy;
- •Current use of psychotropic drug ;
- •Clinical diagnosis of neurological diseases
研究组 & 干预措施
dexmedetomidine
0.5μg/kg bolus injection in 10 minutes followed by 0.1µg/kg/hr pump infusion from 23:30 pm to 6:30 am
干预措施: dexmedetomidine (Drug)
saline
the same rate as dexmedetomidine
干预措施: saline (Drug)
结局指标
主要结局
Sleep efficiency
时间窗: Seven hours from day 0 23:30 to day 1 06:30
measured by polysomnography, Effective sleep time (the sum of non-rapid Eye movement sleep and rapid eye movement sleep time) as a percentage of the monitoring time. Monitoring time is eight hours
次要结局
- Epworth sleeping scale(Day0,Day7)
- Cortisol(Day 0,Day 1)
- BMAL1(Day 0,Day 1)
- Pittsburgh Sleep Quality Index(Day0,Day7)
- Deep brain functional connectivity(Day 0 before 22:00 , Day 3)
- Proteomic analysis(Day 0)
- Insomnia severity index(Day0,Day7)
- Hamilton anxiety scale(Day0,Day7)
- Hamilton depression scale(Day0,Day7)
- N2 sleep time percentage(Seven hours from day 0 23:30 to day 1 06:30)
- Sleep latency(Seven hours from day 0 23:30 to day 1 06:30)
- Brain functional connectivity(Seven hours from day 0 23:30 to day 1 06:30)
- Interleukin-6(IL-6)(Day 0,Day 1)
- Brain-derived neurotrophic factor(BDNF)(Day 0,Day 1)
- Arousal(Seven hours from day 0 23:30 to day 1 06:30)
- Sleep diary (sleep duration,sleep latency,arousal)(Day 1,Day 2,Day 3,Day 4,Day 5,Day 6,Day 7)
