NCT04635098

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 14, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2024

Completed
Last Updated

January 15, 2025

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

November 3, 2020

Last Update Submit

January 13, 2025

Conditions

Chronic Insomnia

Keywords

Chronic insomniaDexmedetomidineCircadian RhythmSleep monitoringBrain functional connectivity

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (16)

  • BMAL1

    Day 0,Day 1

  • Brain functional connectivity

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

  • Interleukin-6(IL-6)

    Day 0,Day 1

  • Brain-derived neurotrophic factor(BDNF)

    Day 0,Day 1

  • N2 sleep time percentage

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

  • +11 more secondary outcomes

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

0.5μg/kg bolus injection in 10 minutes followed by 0.1µg/kg/hr pump infusion from 23:30 pm to 6:30 am

Drug: dexmedetomidine

saline

PLACEBO COMPARATOR

the same rate as dexmedetomidine

Drug: saline

Interventions

dexmedetomidineDRUG

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

Also known as: dexmedetomidine group
dexmedetomidine
salineDRUG

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

Also known as: Placebo group
saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (2)

  • 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.

    PMID: 27571256BACKGROUND

  • 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.

    PMID: 29154132BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 18, 2020

Study Start

May 14, 2021

Primary Completion

June 30, 2023

Study Completion

March 7, 2024

Last Updated

January 15, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication.No end date.
Access Criteria
Anyone who wishes to access the data for any research purpose.They can get all of the individual participant data collected during the trial, after deidentification.Proposals should be directed to d.ma@imperial.ac.uk/yqz12471@rjh.com.cn.To gain access, data requestors will need to sign a data access agreement. Proteomics data will be available at a website(iprox) following publication.

Locations

CN(1)