chronic insomnia
Conditions
Interventions
Comparison group:Sham transcutaneous vagus nerve stimulation
Sponsors
The Affiliated TCM Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria of chronic insomnia in dsm-5 were met; 2. Insomnia symptoms lasted at least 3 months at least 3 nights a week; 3. The age ranged from 18 to 70 years old regardless of gender; 4. Before treatment the total score of Pittsburgh sleep quality index (PSQI) was >= 8; 7 <= Hamilton Anxiety Scale (HAMA) total score <= 14; 7 =<=Hamilton Depression Scale (HAMD) total score <= 17; 5. In the past 1 month he did not take any drugs and substances that may affect the nervous system nor received nerve regulation or acupuncture treatment; 6. It can be treated with auricular point electrical stimulation; 7. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Accompanied by serious physical diseases such as coronary heart disease malignant tumor renal failure etc; 2. Patients with organic brain disease; 3. Accompanied by other mental disorders personality disorders or abuse or dependence of psychoactive substances; 4. Patients who cannot be eluted by drugs or nerve regulation or acupuncture; 5. Pregnant or planned pregnant women and lactating women; 6. External ear deformity ulceration and skin allergy; 7. Unwilling to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at week 8-- the percentage of subjects whose Pittsburgh sleep quality index (PSQI) score decreased by more than 50% from baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate at week 4 and 20-- the percentage of subjects whose Pittsburgh sleep quality index (PSQI) score decreased by more than 50% from baseline.;Hamilton Anxiety Scale;Pittsburgh Sleep Quality Index;Hamilton Depression Scale;Insomnia Severity Index;Flinders Fatigue Scale;Epworth Sleeping Scale;sleep efficacy;wake after sleep onset;sleep onset latency;total sleep time; | — |
Countries
China
Contacts
Public ContactYuting Duan
The Affiliated TCM Hospital of Guangzhou Medical University
Outcome results
None listed