Study for neuroimaging of regulating DMN of insomnia patients by Tiaoshen acupuncture therapy

Phase 1

Recruiting

• Conditions: insomnia

• Registration Number: ITMCTR2200005529
• Lead Sponsor: Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Meeting the above diagnostic criteria of insomnia disorder.
2 Aged 20–60 years.
3 Pittsburgh Sleepiness Scale (PSQI) score > 8.
4 Hamilton Depression Rating Scale (HAMD)score < 7.
5 Hamilton Anxiety Scale (HAMA) score < 14.
6 Hyperarousal Scale (HAS) score > 32.
7 Informed consent signed by the subject themself or an immediate family member.
8 Not taking anti-anxiety, anti-depressant, or sleep medications in the past month
9 No acupuncture treatment for insomnia in recent 1 month
10 Right handed

Exclusion Criteria

1, Depression, anxiety, schizophrenia, or other serious mental illnesses.
2. Severe heart, brain, kidney, or liver disease.
3. Alcohol or drug dependence
4.Failure to cooperate with examination and treatment.
5. Apnea or restless leg syndrome.
6. Pregnant and lactating women.
7. Claustrophobia or other contraindications to MRI examination.
8. A definite lesion on MRI or grossly asymmetrical anatomy of the head

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleepiness Scale (PSQI) score;

Secondary Outcome Measures

Name	Time	Method
Fatigue Scale-14,FS-14;Hamilton depression scale, HAMD;rs-fMRI;Hyperarousal scale,HAS;ActiGraph;Insomnia Severity Index, ISI;Montreal cognitive assessment, MoCA;Hamilton anxiety scale, HAMA;