insomnia
Conditions
Interventions
Experimental group:Auricular acupuncture therapy, alternating between left and right ears, 3 times per week for 4 consecutive weeks.
Control group:Transcutaneous auricular vagus nerve stimulation (taVNS) treatment, twice daily in the morning and evening, for 4 consecutive weeks.
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Meet the diagnostic criteria for chronic insomnia disorder according to DSM-5; (2)Insomnia Severity Index (ISI) score >= 8; (3)Both males and females, aged between 18 and 65 years (inclusive); (4)Have not received acupuncture treatment within the past month; (5)Willing to receive auricular acupoint electrical stimulation treatment; (6)Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who do not meet the above inclusion criteria; (2) Exclude insomnia caused by organic mental disorders or psychoactive substances and non-addictive substances; (3) Those allergic to the experimental auricular acupoint patches or taVNS devices used in this protocol; (4) Those with skin damage at the auricular acupoints or unable to receive treatment due to other reasons; (5) Pregnant, preparing for pregnancy, lactating women, or women who cannot take effective contraceptive measures; (6) Those with severe primary diseases such as cardiovascular, renal, hematopoietic system, liver disease, or mental illness; (7) Those with a history of suicidal tendencies or behaviors, moderate to severe depression (Hamilton Depression Rating Scale HAMD >=18), moderate to severe anxiety (Hamilton Anxiety Rating Scale HAMA >=14), schizophrenia, or other mental disorders; (8) Subjects with alcohol and drug abuse; (9) Those who have participated in other clinical drug or non-drug trials within the past 6 months; (10) Those unable to complete the experiment or deemed ineligible by the researchers for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index scale;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| sleep diary;actigraphy;Heart Rate Variability (HRV);Traditional Chinese Medicine Symptom Checklist;Electroencephalogram;Functional Magnetic Resonance Imaging (fMRI) ; | — |
Countries
China
Contacts
Public ContactWenjing Zhang
Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine
Outcome results
None listed