Study on the effect of vibrating abdomen and ring rubbing method on the functional connectivity of brain network in patients with primary insomnia

Phase 1

• Conditions: insomnia

• Registration Number: ITMCTR2200005832
• Lead Sponsor: Changchun University of Chinese 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

1. Insomnia volunteers were included in the criteria
2. In line with the diagnostic criteria for primary insomnia and deficiency of the heart and spleen, difficulty in sleeping and awakening cannot be better explained by other types of sleep disorders, and the following seven conditions are met:
A. It meets the diagnostic criteria of insomnia disorder and primary insomnia with deficiency of heart and spleen;
B. Aged 50-55 years;
C. Did not participate in other clinical researchers;
D. Signed the informed consent form and volunteered to participate in the study;
E. PSQI > 7 points, AIS > 6 points, SDS and SAS <= 60;
F. No work pressure or life pressure during the observation period;
G. Centerless cerebrovascular diseases and other organic diseases; Physical and chemical indexes of routine hematuria, ELECTROcardiogram, electroencephalogram, liver and kidney function, blood glucose and lipid were normal.
Patients with the above symptoms lasting more than 1 year and with frequency >= 3 times/week can only be included in this study.

Exclusion Criteria

If a subject meets any of the following conditions, he/she will not be allowed to participate in the study.
1. Insomnia patients caused by excessive anxiety and depression;
2. Respiratory related sleep disorders, circadian rhythm sleep disorders and sleep disorders;
3. Insomnia patients suffering from systemic diseases such as pain, fever, cough, etc.;
4. Patients with cardiovascular, lung, liver, kidney, hematopoietic system and other serious primary diseases;
5. Patients with mental illness;
6. The skin at the treatment site is infected or hypersensitive;
7. Patients with progressive malignant tumors or other serious wasting diseases, which are prone to co-infection and bleeding;
8. Patients who have poor compliance, or fail to receive treatment as required;
9. For some reason, it is impossible to judge the curative effect or incomplete data affects the curative effect and judgement;
10. As a result of drug abuse or drug treatment, caused by insomnia patients;
11. Sleep disorders caused by long-term excessive drinking of alcohol, coffee, strong tea, etc., and adverse life factors;
12. A pregnant, menstruating, or lactating woman.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
5-hydroxytryptamine;SP;?-aminobutyric acid;ß-endorphin;PSQI;Resting state functional magnetic resonance imaging of the brain;AIS;