chronic insomnia disorder
Conditions
Interventions
taVNS+rTMS Combined group:taVNS treatment is performed, stimulating the left cavum conchae and cymba conchae. The stimulation parameters are as follows: 4/20 Hz dilation wave (4 Hz for 5 seconds, 20 H
Sham taVNS+rTMS group:Sham taVNS treatment is performed. The stimulation site and parameters are consistent with those of the combination group, but the current intensity is set to 0.1 mA, providing n
taVNS+Sham rTMS group:taVNS treatment is performed, with the stimulation site and parameters consistent with those of the combination group. During the taVNS treatment, sham rTMS stimulation is admini
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meets CI diagnostic criteria; 2. Pittsburgh Sleep Quality Index (PSQI) total score greater than or equal to 8; 3. Age between 18 and 75 years, regardless of gender; 4. Signed informed consent form; Patients must meet all four of the above criteria to be eligible for the study.
Exclusion criteria
Exclusion criteria: 1. History of mental illness, epilepsy, or cognitive impairment; 2. Women who are breastfeeding and/or have a positive urine pregnancy test; 3. Currently using medications that affect autonomic nervous function, such as ß-blockers, anticholinergic drugs, etc.; 4. Presence of contraindications to TMS such as cochlear implants, cardiac pacemakers, or metallic implants in the brain; 5. Skin allergies or ear infections that make taVNS and rTMS interventions unsuitable; 6. Long-term use of insomnia-related medications or use within one month prior to treatment; 7. Individuals deemed unsuitable for participation in the clinical trial by the investigator; Any person who meets any of the above criteria cannot be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Brain-Computer Interface Related Indicators;Functional Near-Infrared Spectroscopy Related Indicators;Resting motor threshold;Autonomic Nervous Function Indicators;Insomnia Severity Index;Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale ;Epworth Sleepiness Scale;Flinders Fatigue Scale; | — |
Countries
China
Contacts
Public ContactPeng Jihai
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed