Chronic Insomnia Clinical Trial
— DOCTOROfficial title:
The Effect of Dexmedetomidine on Patients With Chronic Insomnia and Its Influence on Circadian Rhythm:Randomized Clinical Trial, Double Blind
Verified date | March 2024 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
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
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 |
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