Insomnia Disorder
Conditions
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 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.
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 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.
Interventions
PROCEDUREture acupuncture
ture acupuncture at the Magical-door, Si-shen-cong, Shen-ting, Local-cave acupoints, three times per week and last for 6 weeks
PROCEDUREsham acupuncture
Sham acupuncture at the Magical-door, Si-shen-cong, Shen-ting, Local-cave acupoints, three times per week and last for 6 weeks
Sponsors
Xuanwu Hospital, Beijing
First Affiliated Hospital Xi'an Jiaotong University
Dongfang Hospital Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline brain GABA level at 24 days | at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment | GABA levels in the prefrontal gyrus, occipital gyrus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| brain functional connectivity | at the 24th day after acupuncture treatment | functional connectivity between the medial prefrontal cortex and other brain regions |
| Wake time after sleep onset (WASO) | at the 24th day after acupuncture treatment | WASO is the total time of awake occurring between sleep onset and final wake up |
Countries
China
Contacts
Primary ContactRan Pang, doctor
Backup ContactLi Zhang
Outcome results
None listed