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Chronic InsomniaDOCTORNCT04635098

DexmedetOmidine Complement Treats Chronic insOmnia and Improves Circadian Rhythm (DOCTOR)

A study testing dexmedetomidine and saline in people with Chronic Insomnia, run by Ruijin Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Insomnia
What is being tested?
dexmedetomidine and saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteChina
Study dates
14 May 2021to 7 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Clinical diagnosis of mental disorders;
  • Pregnancy;
  • Current use of psychotropic drug ;
  • Clinical diagnosis of neurological diseases

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

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.

Read the detailed 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.

Being tested
dexmedetomidine, saline
Keywords
Chronic insomnia, Dexmedetomidine, Circadian Rhythm, Sleep monitoring, Brain functional connectivity
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidineDrug

    Also called dexmedetomidine group

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

  • salineDrug

    Also called Placebo group

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

Study groups in NCT04635098
Study groupRoleWhat they receive
dexmedetomidineExperimental0.5μg/kg bolus injection in 10 minutes followed by 0.1µg/kg/hr pump infusion from 23:30 pm to 6:30 am
Receives: Drug: dexmedetomidine
salinePlacebo comparatorthe same rate as dexmedetomidine
Receives: Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Seven hours from day 0 23:30 to day 1 06:30

Secondary outcomes (16)

  1. BMAL1

    sleep protein , Collected from blood lymphocytes

    Measured: Day 0,Day 1

  2. 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

    Measured: Seven hours from day 0 23:30 to day 1 06:30

  3. Interleukin-6(IL-6)

    cytokines，Collected from blood

    Measured: Day 0,Day 1

  4. Brain-derived neurotrophic factor(BDNF)

    Collected from blood

    Measured: Day 0,Day 1

  5. N2 sleep time percentage

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

    Measured: Seven hours from day 0 23:30 to day 1 06:30

  6. 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

    Measured: Day 0 before 22:00 , Day 3

  7. Cortisol

    Collected from blood

    Measured: Day 0,Day 1

  8. 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

    Measured: Day 0

  9. Sleep latency

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

    Measured: Seven hours from day 0 23:30 to day 1 06:30

  10. 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.

    Measured: Seven hours from day 0 23:30 to day 1 06:30

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

    for one week after treatment recorded by the subjects themselves

    Measured: Day 1,Day 2,Day 3,Day 4,Day 5,Day 6,Day 7

  12. 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.

    Measured: Day0,Day7

  13. 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.

    Measured: Day0,Day7

  14. 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.

    Measured: Day0,Day7

  15. 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.

    Measured: Day0,Day7

  16. 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.

    Measured: Day0,Day7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start14 May 2021
  3. Primary completion30 Jun 2023
  4. Study completion7 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04635098
Sponsor's protocol ID
DOCTOR-super LuoMa
Acronym
DOCTOR
Status last verified
Mar 2024
First submitted
3 Nov 2020
Last updated
15 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • 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.

    PubMed 27571256

  • 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.

    PubMed 29154132

Questions about this trial

What is this clinical trial studying?

A study testing dexmedetomidine and saline in people with Chronic Insomnia, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep efficiency (time frame: Seven hours from day 0 23:30 to day 1 06:30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04635098, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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