An interventional study of dexmedetomidine and saline in Chronic Insomnia, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 64 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
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
the same rate as dexmedetomidine
Drug: saline
All participants will be randomly assigned to receive either dexmedetomidine or saline
Also known as: dexmedetomidine group
All participants will be randomly assigned to receive either dexmedetomidine or saline
Also known as: Placebo group
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
Time frame: Seven hours from day 0 23:30 to day 1 06:30
BMAL1
sleep protein , Collected from blood lymphocytes
Time frame: Day 0,Day 1
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
Time frame: Seven hours from day 0 23:30 to day 1 06:30
Interleukin-6(IL-6)
cytokines，Collected from blood
Time frame: Day 0,Day 1
Brain-derived neurotrophic factor(BDNF)
Collected from blood
Time frame: Day 0,Day 1
N2 sleep time percentage
measured by polysomnography，N2 sleep time as a percentage of total monitoring time. Monitoring time is eight hours
Time frame: Seven hours from day 0 23:30 to day 1 06:30
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
Time frame: Day 0 before 22:00 , Day 3
Cortisol
Collected from blood
Time frame: Day 0,Day 1
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
Time frame: Day 0
Sleep latency
measured by polysomnography，the time required from getting ready to go to bed to actually falling asleep
Time frame: Seven hours from day 0 23:30 to day 1 06:30
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.
Time frame: Seven hours from day 0 23:30 to day 1 06:30
Sleep diary (sleep duration,sleep latency,arousal)
for one week after treatment recorded by the subjects themselves
Time frame: Day 1,Day 2,Day 3,Day 4,Day 5,Day 6,Day 7
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.
Time frame: Day0,Day7
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.
Time frame: Day0,Day7
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.
Time frame: Day0,Day7
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.
Time frame: Day0,Day7
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.
Time frame: Day0,Day7
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: 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.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Sleep Initiation and Maintenance Disorders →