Study on the central mechanism of acupuncture therapy for insomnia based on fMRI technology
- Conditions
- insomnia
- Registration Number
- ITMCTR2000004142
- Lead Sponsor
- the Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Subjects with insomnia: Meet the fulfilled criteria for insomnia in the Diagnostic and Statistical Manual and for general insomnia in International Classification of Sleep Disorders; Aged between 1865 years, dextromanuality; A ISI score > 14 points; The duration of the disease was > 3 months, or the relapse was > 6 months; Did not participate in other clinical studies during the same period; Signed informed consent form and volunteered to participate in this study;
2. Normal subject: Have no insomnia, and does not meet the diagnostic criteria for insomnia; Aged between 1865 years, dextromanuality; A ISI score < 7 points; Did not participate in other clinical studies during the same period; Signed informed consent form and volunteered to participate in this study.
1. Subjects with insomnia: Sleep disturbance caused by external environment interference; Sleep disorders caused by drugs or life factors such as alcohol, coffee or strong tea; Sleep disturbances caused by severe primary diseases (cardiovascular, pulmonary, liver, etc.), severe deeline (malignant tumors, etc.), and systemic diseases (pain, fever, surgery, etc.);Pregnancy or lactation; Persons diagnosed with mental illness or bipolar disorder; Psychiatric conditions requiring treatment, including GAD-7 score> 10 points, PHQ-9 score> 10 points; Severe depression recurs>2 times; Risk of suicide and self-injury; Diagnosis of other sleep disorders, including obstructive sleep apnea or circadian sleep disorders; Used hypnotic or sedative drugs to treat insomnia in the last 4 weeks; Alcohol and drug dependence in the previous 1 year; Night shift or irregular sleep pattern; Received acupuncture or Traditional Chinese medicine treatment in recent 2 months; Existing progressive diseases (such as dementia, Parkinson's disease, tumor, etc.) directly related to the onset and course of insomnia; Contraindications for MRI(pacemaker, cochlear implant, claustrophobia, etc.); History of neurological diseases (brain tumors, epilepsy, cerebrovascular accidents, etc.); History of severe head trauma (loss of consciousness >10 min);With acupoint infect or afraid of acupuncture.
2.Normal subject: Pregnancy or lactation; Previously diagnosed as depression, anxiety disorder, bipolar disorder or other mental disorders, or GAD-7 score > 5 points, or PHQ-9 score > 5 points in this study; Risk of suicide and self-injury; Used hypnotic or sedative drugs to treat insomnia in the last 4 weeks; Alcohol and drug dependence in the previous 1 year; Night shift or irregular sleep pattern; Received acupuncture or Traditional Chinese medicine treatment in recent 2 months; With severe primary diseases (cardiovascular, lung, liver, etc.), severe wasting diseases (malignant tumors, etc.), and systemic diseases (pain, fever, surgery, etc.); Contraindications for MR (pacemaker, cochlear implant, claustrophobia, etc.); History of neurological diseases (brain tumors, epilepsy, cerebrovascular accidents, etc.); History of severe head trauma (loss of consciousness >10 min.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index ;Functional magnetic resonance imaging;The Montreal Cognitive Assessment;
- Secondary Outcome Measures
Name Time Method Consensus Sleep Diary;The Epworth Sleepiness Scale;Positive and Negative Affect Schedule;Insomnia Severity Index;