Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04635098
Study type Interventional
Source Ruijin Hospital
Contact
Status Completed
Phase N/A
Start date May 14, 2021
Completion date March 7, 2024

See also
  Status Clinical Trial Phase
Completed NCT03171519 - Effects of Exercise and Acupuncture on Chronic Insomnia N/A
Completed NCT02515006 - Impact of Homeopathy for Persistent Insomnia in Patients With Cancer N/A
Recruiting NCT05247697 - Mirtazapine for Chronic Insomnia in Older Adults Phase 1
Active, not recruiting NCT04366284 - Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform N/A
Active, not recruiting NCT04350866 - Enhancing Access to Insomnia Care in VA PCMHI Clinics
Recruiting NCT04761796 - Sleep Time and Insomnia Factors Among Professional Flight Members
Completed NCT02688569 - Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study N/A
Completed NCT02236845 - Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients N/A
Completed NCT01949389 - Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders N/A
Completed NCT00414102 - Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia. Phase 4
Completed NCT00671294 - Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia. Phase 3
Completed NCT02392000 - Mobile Sleep Intervention for OEF, OIF and OND Veterans N/A
Recruiting NCT04471168 - Interest of Auriculotherapy in the Management of Chronic Insomnia N/A
Completed NCT02774642 - Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study) N/A
Completed NCT02290405 - Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Completed NCT05618002 - Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
Completed NCT01995838 - A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia Phase 2
Recruiting NCT05457790 - Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD) N/A
Completed NCT02272712 - The Effectiveness of Online Treatment for Insomnia in Cancer Survivors N/A
Completed NCT00915135 - Efficacy and Safety of Ramelteon on Chronic Insomnia Phase 2