Study on the clinical effect of acupuncture versus cognitive behavioral therapy in treating primary insomnia and the difference of brain network regulation mechanism

Not Applicable

• Conditions: insomnia

• Registration Number: ITMCTR2200005912
• Lead Sponsor: Daping Hospital,Army Medical University

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) Meet the diagnostic criteria of primary insomnia in International Classification of Sleep Disorders (ICSD-3);
2) Age: 18-50;
3) Education level: primary school or above, able to independently complete neuropsychological sleep related scale assessment;
4) I voluntarily participate in this study with informed consent and signature.
Note: Subjects who meet the above 4 criteria at the same time can be included in this study.

Exclusion Criteria

1) Those who have received acupuncture treatment or cognitive behavioral therapy for insomnia in the past 3 months;
2) Have received sedative-hypnotic drugs or insomnia patients with unknown treatment history within the past 1 month;
3) Insomnia patients suffering from anxiety, depression and other mental disorders;
4) Insomnia patients with cognitive dysfunction;
5) Suffering from other sleep disorders (such as restless leg syndrome, sleep apnea, narcolepsy, etc.), systemic diseases (such as pain, fever, cough, surgery, etc.), endocrine diseases such as hyperthyroidism, and external environmental interference factors;
6) Patients with respiratory, heart, liver, kidney and other organic diseases, hypertension, diabetes, hyperlipidemia and poorly controlled, patients with neurological diseases, malignant tumors, pregnancy/lactation;
7) History of serious smoking, alcohol and drug abuse;
8) Mr Scan contraindications: metal implants, claustrophobia, etc.;
9) Change in sleeping or waking time > 3 hours due to work and personal preference (staying up late or working shifts recently).
10) Patients with severe infection at the acupuncture site, or those who are afraid of or refuse acupuncture;
11) Participate in other clinical investigators.
Note: Patients who met any of the above criteria were excluded from this study.?? Note: subjects who meet the above 4 criteria can be included in this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
PSQI;

Secondary Outcome Measures

Name	Time	Method
PSG;HAMD;ISI;HAMA;MRI;