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临床试验/NCT04635098
NCT04635098已完成不适用

The Effect of Dexmedetomidine on Patients With Chronic Insomnia and Its Influence on Circadian Rhythm:Randomized Clinical Trial, Double Blind

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年5月14日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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