Exploring the brain mechanisms of transcutaneous auricular vagus nerve stimulation for patients with insomnia based on multimodal magnetic resonance imaging

Not Applicable

• Conditions: Insomnia Disorder

• Registration Number: ITMCTR2100005324
• Lead Sponsor: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

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) Conformity to the diagnostic standards of the American Diagnostic and Statistical Manual of Mental Disorders (5th edition) for PI. 2) Insomnia symptoms lasting for > 3 months, =3 times per week. 3) 18 to 70 years old, right-handed. 4) Pittsburgh sleep quality index (PSQI) score=8,17 items of the Hamilton Depression Scale =17 and 14 items of the Hamilton Anxiety Scale =14. 5) Not taking any neuropsychiatric medications or substances and not receiving acupuncture treatment in the past month. 6) Cooperate to accept the treatment of auricular electrical stimulation and complete the acquisition of magnetic resonance data. 7) Signed the informed consent form..

Exclusion Criteria

1) Patients with severe physical diseases, such as coronary heart disease, malignant tumor and renal failure. 2) Patients with brain organic diseases. 3) Combined with any other mental disorder, personality disorder or psychoactive substance abuse or dependence. 4) Patients who cannot elute from medicine or acupuncture treatment. 5) Pregnant and lactating women. 6) Patients with contraindications of magnetic resonance imaging (MRI). 7)Patients with damaged ear skin. 8)Patients who were unwilling to sign inform consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
MRI;PSQI;

Secondary Outcome Measures

Name	Time	Method
ISI;FFS;HAMA-14;ESS;HAMD-17;