Study on the central mechanism of acupuncture therapy for insomnia based on fMRI technology

Phase 1

• Conditions: insomnia

• Registration Number: ITMCTR2000004139
• Lead Sponsor: the Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional study
• Study Design: Not specified