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Completed

NCT Number: NCT04635098

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.

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: dexmedetomidine group

Saline

Drug

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

Other names: Placebo group

Primary outcomes

  1. Sleep efficiency

    Time frame: 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

Secondary outcomes

  1. BMAL1

    Time frame: Day 0,Day 1

    sleep protein , Collected from blood lymphocytes

  2. Brain functional connectivity

    Time frame: Seven hours from day 0 23:30 to day 1 06:30

    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

  3. Interleukin-6(IL-6)

    Time frame: Day 0,Day 1

    cytokines，Collected from blood

  4. Brain-derived neurotrophic factor(BDNF)

    Time frame: Day 0,Day 1

    Collected from blood

  5. N2 sleep time percentage

    Time frame: Seven hours from day 0 23:30 to day 1 06:30

    measured by polysomnography，N2 sleep time as a percentage of total monitoring time. Monitoring time is eight hours

  6. Deep brain functional connectivity

    Time frame: Day 0 before 22:00 , Day 3

    we will analysis the brain connection network according to the functional magnetic resonance imaging nonlinear Granger predictive analysis (Granger causality analysis, GCA) method

  7. Cortisol

    Time frame: Day 0,Day 1

    Collected from blood

  8. Proteomic analysis

    Time frame: Day 0

    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

  9. Sleep latency

    Time frame: Seven hours from day 0 23:30 to day 1 06:30

    measured by polysomnography，the time required from getting ready to go to bed to actually falling asleep

  10. Arousal

    Time frame: Seven hours from day 0 23:30 to day 1 06:30

    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.

  11. Sleep diary (sleep duration,sleep latency,arousal)

    Time frame: Day 1,Day 2,Day 3,Day 4,Day 5,Day 6,Day 7

    for one week after treatment recorded by the subjects themselves

  12. Pittsburgh Sleep Quality Index

    Time frame: Day0,Day7

    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.

  13. Insomnia severity index

    Time frame: Day0,Day7

    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.

  14. Epworth sleeping scale

    Time frame: Day0,Day7

    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.

  15. Hamilton anxiety scale

    Time frame: Day0,Day7

    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.

  16. Hamilton depression scale

    Time frame: Day0,Day7

    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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: DOCTOR

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 18, 2020
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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