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Observation of the clinic efficacy and brain mechanism of transcutaneous auricular vagus nerve electroacupuncture in the treatment of chronic insomnia at different frequencies

Observation of the clinic efficacy and brain mechanism of transcutaneous auricular vagus nerve electroacupuncture in the treatment of chronic insomnia at different frequencies

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071158
Enrollment
Unknown
Registered
2023-05-06
Start date
2023-05-31
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic insomnia

Interventions

a-wave group:5 Hz frequency taVNS treatment.
?-wave group:10 Hz frequency taVNS treatment.
?-wave group:40 Hz frequency taVNS treatment.
Control group:None

Sponsors

Guang'anmen Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 55 Years

Inclusion criteria

Inclusion criteria: ?Age between 40 and 55 years old, regardless of gender; ?Right-handedness; ?Meet the diagnostic criteria for IS in the American Diagnostic and Statistical Manual of Mental Disorders, 5th edition; symptoms lasting 3 months or longer; no relevant treatment within the last 2 weeks; ?Previous physical fitness, no psychiatric or neurological abnormalities, no history of traumatic brain injury, history of surgery, etc; ? No contraindications to functional MRI, such as metal placement in the body, claustrophobia, etc; ?The procedure, purpose, potential discomfort and risks of the test were explained to all subjects before the examination, and the subjects voluntarily participated in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: ? physical illnesses such as central nervous system disorders, substance abuse, alcohol abuse, and cardiovascular disease; ? other chronic diseases that may affect cognitive function; ?A history of mental illness and family history; ?People with claustrophobia; people with metal residues in the body, deep vein placement, etc. who are unable to perform MRI scans or whose image quality is affected.

Design outcomes

Primary

MeasureTime frame
fMRI;MRS;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index , PSQI;Hyper-arousal Scale, HAS;Athens Insomnia Scale, AIS;Insomnia Severity Index, ISI;HAMD;HAMA;

Countries

china

Contacts

Public ContactYanping Zhao

Guang'anmen Hospital China Academy of Chinese Medical Sciences

zhaoyp99999@163.com+86 13269443949

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026