Study on Electrophysiological Mechanism and Intervention Effectiveness of Insomnia Based on Abdominal Acupuncture and tACS Regulation Technology
- Conditions
- Insomnia and drug-dependent insomnia
- Registration Number
- ITMCTR2100004293
- Lead Sponsor
- Department of Health management, Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Healthy control group
Aged 18-65 years; No history of sleep disorder; PSQI<7 Good sleep quality, no history of alternating working hours between day and night; No neurological or mental diseases, such as depression and anxiety (HAMD=7, HAMA < 7); No other sleep disorders; Right-handed.
2. Patients with primary insomnia
(1) meet the diagnostic criteria of insomnia, right-handed;
(2) The patient is conscious, without aphasia and intelligence disorder, and can understand the contents of the scale and cooperate with the treatment;
(3) The total score of Pittsburgh Sleep Quality Index (PSQI) is >= 7;
(4) There are no serious organic diseases such as cardiovascular diseases, hepatic and renal insufficiency and mental illness.
(5) Those aged 18-65 who are willing to accept this treatment and insist on treatment;
(6) Volunteer to participate and sign informed consent.
(7) Hamilton Anxiety Scale (HAMA) score <= 14;
(8) Hamilton Depression Scale (HAMD) score <= 17.
3. Patients with EDIAD
(1) Meet the diagnostic criteria of Chinese and Western medicine for insomnia and hypnotic drug-dependent sleep disorder, take estazolam for 1-2mg >= 6 months, and use your right hand;
(2) The patient is conscious, without aphasia and intelligence disorder, and can understand the contents of the scale and cooperate with the treatment;
(3) The total score of Pittsburgh Sleep Quality Index (PSQI) is >= 7;
(4) There are no serious organic diseases such as cardiovascular diseases, hepatic and renal insufficiency and mental illness. (5) Those aged 40-65 who are willing to accept this treatment and insist on treatment;
(6) Volunteer to participate and sign informed consent.
(7) The total score of Hamilton Anxiety Scale (HAMA) is 7-21;
(8) The total score of Hamilton Depression Scale (HAMD) is > 7 and <= 17.
Patients with primary insomnia
(1) do not meet the above conditions; ? Those who use other drugs to treat insomnia; ? Insomnia caused by drugs, emergency events, environmental and psychological factors and bad habits; ? Insomnia caused by severe neurasthenia, stress disorder, personality disorder, organic diseases and psychoactive substances; ? The living environment (objectively) will change greatly during the observation period; ? Severe liver and kidney insufficiency, or serious diseases of various systems; ? Those who cannot insist on treatment due to long distance or other reasons; 8 pregnant women, lactating women and other special groups; Those who meet any of the above items are not allowed to join the group.
Group of EDIAD patients
(1) do not meet the above conditions; ? Those who use drugs other than estazolam to treat insomnia; ? Insomnia caused by drugs, emergency events, environmental and psychological factors and bad habits; ? Insomnia caused by severe neurasthenia, stress disorder, personality disorder, organic diseases and psychoactive substances; ? According to the researcher's judgment, there are other situations that have the possibility of low enrollment or complicate enrollment, such as frequent changes in the working environment and frequent business trips; 6 pregnant women, lactating women, high fever, coagulation dysfunction; ? Severe hepatic and renal insufficiency, or complicated with serious diseases of various systems; ? Alcoholism or other material dependence; Pet-name ruby due to distance or other reasons can't insist on treatment; Attending external use of alcohol allergy or allergic to acupuncture needles; Abdominal organ diseases or abdominal scars affect those who apply needles in the abdomen; Patients who adopt other treatment schemes or participate in other clinical studies; Those who meet any of the above items are not allowed to join the group.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dosage of estazolam;Pittsburgh Sleep Quality Index;Drug reduction rate of estazolam;
- Secondary Outcome Measures
Name Time Method Hamilton Anxiety Scale;Hamilton Depression Scale;Benzodiazepine Withdrawal Symptom Questionnaire;EEG;