Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04635098
Other study ID # DOCTOR-super LuoMa
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2021
Est. completion date March 7, 2024

Study information

Verified date March 2024
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 7, 2024
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Clinical diagnosis of mental disorders; - Pregnancy; - Current use of psychotropic drug ; - Clinical diagnosis of neurological diseases

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
dexmedetomidine
All participants will be randomly assigned to receive either dexmedetomidine or saline
saline
All participants will be randomly assigned to receive either dexmedetomidine or saline

Locations

Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Akeju O, Hobbs LE, Gao L, Burns SM, Pavone KJ, Plummer GS, Walsh EC, Houle TT, Kim SE, Bianchi MT, Ellenbogen JM, Brown EN. Dexmedetomidine promotes biomimetic non-rapid eye movement stage 3 sleep in humans: A pilot study. Clin Neurophysiol. 2018 Jan;129(1):69-78. doi: 10.1016/j.clinph.2017.10.005. Epub 2017 Oct 20. — View Citation

Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep efficiency 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 Seven hours from day 0 23:30 to day 1 06:30
Secondary BMAL1 sleep protein , Collected from blood lymphocytes Day 0,Day 1
Secondary Brain functional connectivity According to the collected scalp EEG frequency domain and time domain data, the coherence method is used to measure the phase synchronization degree of different brain regions Seven hours from day 0 23:30 to day 1 06:30
Secondary Interleukin-6(IL-6) cytokines,Collected from blood Day 0,Day 1
Secondary Brain-derived neurotrophic factor(BDNF) Collected from blood Day 0,Day 1
Secondary N2 sleep time percentage measured by polysomnography,N2 sleep time as a percentage of total monitoring time. Monitoring time is eight hours Seven hours from day 0 23:30 to day 1 06:30
Secondary Deep brain functional connectivity we will analysis the brain connection network according to the functional magnetic resonance imaging nonlinear Granger predictive analysis (Granger causality analysis, GCA) method Day 0 before 22:00 , Day 3
Secondary Cortisol Collected from blood Day 0,Day 1
Secondary Proteomic analysis Due to some patients having a good response to Dex treatment, while others had rather limited efficacy, we further investigated the proteomic differences in peripheral blood between effective and ineffective patients before their treatment.Screening differential proteins between two groups in the protein database through proteomic analysis results in peripheral blood samples Day 0
Secondary Sleep latency measured by polysomnography,the time required from getting ready to go to bed to actually falling asleep Seven hours from day 0 23:30 to day 1 06:30
Secondary Arousal measured by polysomnography including arousal > 15 sec(times), micro arousal(times) and wake duration after sleep onset(min).These indicators are used to evaluate the number of awakenings during sleep and the total duration of awakenings. Seven hours from day 0 23:30 to day 1 06:30
Secondary Sleep diary (sleep duration,sleep latency,arousal) for one week after treatment recorded by the subjects themselves Day 1,Day 2,Day 3,Day 4,Day 5,Day 6,Day 7
Secondary Pittsburgh Sleep Quality Index Scale to assess sleep quality,the lower the score, the better the sleep quality.The minimum value is 0 points, and the maximum value is 21 points. Day0,Day7
Secondary Insomnia severity index Scale to assess severity of insomnia,the higher the score, the more severe the insomnia will be.The minimum value is 0 points, and the maximum value is 28 points. Day0,Day7
Secondary Epworth sleeping scale A scale for evaluating daytime sleepiness, with higher scores indicating greater daytime sleepiness in subjects.The minimum value is 0 points, and the maximum value is 24 points. Day0,Day7
Secondary Hamilton anxiety scale A scale for assessing anxiety levels, where the higher the score, the more anxious the subject is.daytime sleepiness in subjects.The minimum value is 0 points, and the maximum value is 56 points. Day0,Day7
Secondary Hamilton depression scale A scale for assessing the degree of depression, with higher scores indicating greater depression among participants.
0-7 points: No depressive symptoms or normal level; 8-13 points: Mild depressive symptoms; 14-18 points: moderate depressive symptoms; 19-22 points: symptoms of moderate to severe depression; 23 points or above: severe depressive symptoms.
Day0,Day7
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 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