Study on the central nervous mechanism of three-part tui na manipulation in primary insomnia

Phase 1

• Conditions: Primary insomnia

• Registration Number: ITMCTR2200006789
• Lead Sponsor: The Third Affiliated Hospital of Henan University of Traditional 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)meet the diagnostic criteria of primary insomnia;
(2)are aged between 18 and 65 years ,male or female;
(3)Pittsburgh Sleep Index (PSQI) > 7, AIS scale > 6;
(4) have not received any treatment within 1 month,including acupuncture and medicine;
(5)have not taken any other sleeping medicine within 2 weeks;
(6)have not participated in other clinical research;
(7)have signed an informed consent.

Exclusion Criteria

(1)insomnia caused by external environmental interference;
(2)insomnia caused by drug or alcohol or coffee or strong tea;
(3)experience breathing-related sleep disorders, circadian rhythm sleep disorders and sleep disorders;
(4)insomnia caused by severe pain or fever or surgery;
(5)insomnia caused by psychiatric,neurological, cardiovascular, infectious,immunological;
(6)taken any other sleeping medicine within 2 weeks;
(7)skin damage in the treatment area;
(8)having MRI contraindications such as claustrophobia, cardiac pacemaker, defibrillator, heart stenting;
(9)pregnant,breast-feeding, or having plans to conceive;
(10) have not signed an informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep quality Index score;

Secondary Outcome Measures

Name	Time	Method
Hyperarousal Scale;HamiltonAnxietySclae;17-item version of Hamilton Depression Scale;Fatigue Scale-14;Resting state functional magnetic resonance scanning;