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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insomnia-ture acupuncture | Experimental | True acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture |
|
| Insomnia-sham acupuncture | Sham Comparator | Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ture acupuncture | Procedure | ture acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline brain GABA level at 24 days | GABA levels in the prefrontal gyrus, occipital gyrus | at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment |
| Measure | Description | Time Frame |
|---|---|---|
| brain functional connectivity | functional connectivity between the medial prefrontal cortex and other brain regions | at the 24th day after acupuncture treatment |
| Wake time after sleep onset (WASO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ran Pang, doctor | Contact | 861067693481 | pangrandf@163.com | |
| Li Zhang | Contact | 861067689644 | zhanglidf2017@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongfang Hospital Affiliated to Beijing University of Chinese Medicine | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| sham acupuncture | Procedure | Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks |
|
WASO is the total time of awake occurring between sleep onset and final wake up
| at the 24th day after acupuncture treatment |
| D001523 |
| Mental Disorders |