ITMCTR2000004139尚未招募1 期
Study on the central mechanism of acupuncture therapy for insomnia based on fMRI technology
the Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •Subjects with insomnia:
- •(1) Meet the fulfilled criteria for insomnia in the Diagnostic and Statistical Manual and for general insomnia in International Classification of Sleep Disorders;
- •(2) Aged between 18-65 years, dextromanuality;
- •(3) A ISI score > 14 points;
- •(4) The duration of the disease was > 3 months, or the relapse was > 6 months;
- •(5) Did not participate in other clinical studies during the same period;
- •(6) Signed informed consent form and volunteered to participate in this study.
- •Normal subject:
- •(1) Have no insomnia, and does not meet the diagnostic criteria for insomnia;
- •(2) Aged between 18-65 years, dextromanuality;
- •(3) A ISI score <7 points;
- •(4) Did not participate in other clinical studies during the same period;
- •(5) Signed informed consent form and volunteered to participate in this study.
排除标准
- •Subjects with insomnia:
- •(1) Sleep disturbance caused by external environment interference;
- •(2) Sleep disorders caused by drugs or life factors such as alcohol, coffee or strong tea;
- •(3) Sleep disturbances caused by severe primary diseases (cardiovascular, pulmonary, liver, etc.), severe deeline (malignant tumors, etc.), and systemic diseases (pain, fever, surgery, etc.);
- •(4) Pregnancy or lactation;
- •(5) Persons diagnosed with mental illness or bipolar disorder;
- •(6) Psychiatric conditions requiring treatment, including GAD-7 score> 10 points[31], PHQ-9 score> 10 points[32];
- •(7) Severe depression recurs>2 times
- •(8) Risk of suicide and self-injury;
- •(9) Diagnosis of other sleep disorders, including obstructive sleep apnea or circadian sleep disorders;
- •(10) Used hypnotic or sedative drugs to treat insomnia in the last 4 weeks;
- •(11) Alcohol and drug dependence in the previous 1 year;
- •(12) Night shift or irregular sleep pattern;
- •(13) Received acupuncture or Traditional Chinese medicine treatment in recent 2 months;
- •(14) Existing progressive diseases (such as dementia, Parkinson's disease, tumor, etc.) directly related to the onset and course of insomnia;
- •(15) Contraindications for MRI(pacemaker, cochlear implant, claustrophobia, etc.);
- •(16) History of neurological diseases (brain tumors, epilepsy, cerebrovascular accidents, etc.);
- •(17) History of severe head trauma (loss of consciousness >10 min)
- •(18) With acupoint infect or afraid of acupuncture.
- •Normal subject:
- •(1) Pregnancy or lactation;
- •(2) Previously diagnosed as depression, anxiety disorder, bipolar disorder or other mental disorders, or GAD-7 score > 5 points[31], or PHQ-9 score > 5 points [32]in this study;
- •(3) Risk of suicide and self-injury;
- •(4) Used hypnotic or sedative drugs to treat insomnia in the last 4 weeks;
- •(5) Alcohol and drug dependence in the previous 1 year;
- •(6) Night shift or irregular sleep pattern;
- •(7) Received acupuncture or Traditional Chinese medicine treatment in recent 2 months;
- •(8) With severe primary diseases (cardiovascular, lung, liver, etc.), severe wasting diseases (malignant tumors, etc.), and systemic diseases (pain, fever, surgery, etc.);
- •(9) Contraindications for MR (pacemaker, cochlear implant, claustrophobia, etc.);
- •(10) History of neurological diseases (brain tumors, epilepsy, cerebrovascular accidents, etc.);
- •(11) History of severe head trauma (loss of consciousness >10 min).
研究者
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