insomnia
Conditions
Interventions
Sponsors
the Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| the Insomnia Severity Index;the Consensus Sleep Diary;The Epworth Sleepiness Scale;the Positive and Negative Affect Schedule;The Montreal Cognitive Assessment; | — |
Countries
China
Contacts
Public ContactLize Xiong
the Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
Outcome results
None listed