DexmedetOmidine Complement Treats Chronic insOmnia and Improves Circadian Rhythm (DOCTOR)
DexmedetOmidine Complement Treats Chronic insOmnia and Improves Circadian Rhythm (DOCTOR)
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.
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.
Inclusion Criteria:

 -  Age between 30- 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

 Exclusion Criteria:

 -  Clinical diagnosis of mental disorders;

 -  Pregnancy;

 -  Current use of psychotropic drug ;

 -  Clinical diagnosis of neurological diseases