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Recruiting NCT06969040

NCT06969040 The Effect of Standard Cognitive-behavioral Therapy+Transcranial Alternating Current on Refractory Insomnia Disorder

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Clinical Trial Summary
NCT ID NCT06969040
Status Recruiting
Phase
Sponsor Xuanwu Hospital, Beijing
Condition Insomnia
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2024-11-01
Primary Completion 2025-10-01

Trial Parameters

Condition Insomnia
Sponsor Xuanwu Hospital, Beijing
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-01
Completion 2025-10-01
Interventions
CBTI + tACSCBTI + Sham tACS

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Brief Summary

The main purpose of this study is to investigate the efficacy of CBTI + transcranial alternating current (TAC) technology in the treatment of refractory insomnia and the mechanism of 'cognitive-behavioural-brain network' interactions.

Eligibility Criteria

Inclusion Criteria: 1. Meets the diagnostic criteria for insomnia in DSM-5; 2. Pittsburgh Sleep Quality Index (PSQI) total score\>5 points; 3. Age ≥ 18 years old, with a junior high school education or above; 4. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: 1. Individuals with severe physical or mental illnesses are at risk of suicide; 2. Clinically diagnosed or suspected sleep breathing disorders, restless leg syndrome, and sleep wake rhythm disorders, as well as workers on rotating shifts; 3. Pregnant and lactating women; 4. Currently undergoing any psychological therapy.

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