Chronic Insomnia Clinical Trial
Official title:
The Effect of Dexmedetomidine on Patients With Chronic Insomnia and Its Influence on Circadian Rhythm:Randomized Clinical Trial, Double Blind
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. ;
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 |
NCT04350866 -
Enhancing Access to Insomnia Care in VA PCMHI Clinics
|
||
Active, not recruiting |
NCT04366284 -
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
|
N/A | |
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 |