An interventional study of ture acupuncture and sham acupuncture in Insomnia Disorder, sponsored by Dongfang Hospital Beijing University of Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-09.
Sponsored by Dongfang Hospital Beijing University of Chinese Medicine · Not applicable, Interventional, and Basic science
Insomnia disorder is one of the major neuropsychiatric diseases which received more attention in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on insomnia symptom. However, the underlying mechanism remains unclear. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA levels between pro- and post-acupuncture treatment in individuals with chronic insomnia disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to determine whether CID patients have altered brain connectivity and network parameter changes. The investigators are also exploring the correlation between cortical GABA levels, fMRI parameter changes and abnormalities in sleep parameters and neuropsychology test in CID patients.
Three groups of subjects (CID accepted true acupuncture, CID accepted sham acupuncture and healthy) will participate in the study. All subjects will undergo a laboratory blood test, physical and neurological examination, polysomnography (PSG) and an extensive battery of neuropsychological assessments. All subjects meeting eligibility criteria for the study will complete a baseline MRS and fMRI to evaluate differences in multi-modality brain GABA and fMRI parameters between the patients and healthy. After randomized acupuncture treatment, investigators will compare brain metabolic and functional parameters to elucidate the neural mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the perspective of neurotransmitters and brain network.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Dongfang Hospital Beijing University of Chinese Medicine is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
True acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture
Procedure: ture acupuncture
Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture
Procedure: sham acupuncture
ture acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks
Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks
change from baseline brain GABA level at 24 days
GABA levels in the prefrontal gyrus, occipital gyrus
Time frame: at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment
brain functional connectivity
functional connectivity between the medial prefrontal cortex and other brain regions
Time frame: at the 24th day after acupuncture treatment
Wake time after sleep onset (WASO)
WASO is the total time of awake occurring between sleep onset and final wake up
Time frame: at the 24th day after acupuncture treatment
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Dongfang Hospital Beijing University of Chinese Medicine