Status:
UNKNOWN
The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI
Lead Sponsor:
Dongfang Hospital Beijing University of Chinese Medicine
Collaborating Sponsors:
Xuanwu Hospital, Beijing
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Insomnia Disorder
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
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 hyper...
Detailed Description
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 neuro...
Eligibility Criteria
Inclusion
- Clinical diagnosis of chronic insomnia disorder (CID) met the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Subject has history of chronic insomnia (difficulty with sleep induction, awakenings during the night, early morning awakening) of at least 3 months
- Must be able to cooperate with cognitive testing and MRI scan
Exclusion
- Known pre-existing sleep disorder other than chronic insomnia disorder
- Circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work time at day and night alternation)
- Severe general medical disorders of cardiovascular, endocrine, renal, or hepatic systems
- Clinical diagnosis of AD or Parkinson's neurodegenerative diseases
- Moderate or severe psychological illness
- Clinical history of stroke or other severe cerebrovascular disease
- Clinical history of malignancies disease
- Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
- Alcohol or drug abuse
Key Trial Info
Start Date :
December 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03237338
Start Date
December 26 2017
End Date
December 31 2021
Last Update
July 9 2021
Active Locations (1)
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1
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, China