Chronic Insomnia Disorder
Conditions
Interventions
the 30min group:Transcutaneous Vagus Nerve Stimulation (tVNS) is administered using 4/20 Hz expansive waves (4 Hz for 5 seconds and 20 Hz for 10 seconds, alternating, default parameters of the device)
the 15min group:Transcutaneous Vagus Nerve Stimulation (tVNS) is administered using 4/20 Hz expansive waves (4 Hz for 5 seconds and 20 Hz for 10 seconds, alternating, default parameters of the device)
the 5min group:Transcutaneous Vagus Nerve Stimulation (tVNS) is administered using 4/20 Hz expansive waves (4 Hz for 5 seconds and 20 Hz for 10 seconds, alternating, default parameters of the device),
Sponsors
Chinese PLA General Hosptial
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for insomnia disorder according to DSM-5 ; 2.Insomnia symptoms have persisted for more than 3 months; 3.Aged 18–65 years (inclusive of the boundary values); 4.Pittsburgh Sleep Quality Index (PSQI) score >= 8; Self-Rating Anxiety Scale (SAS) score = 59; Self-Rating Depression Scale (SDS) score <= 62; 5.No use of any drugs or substances acting on the nervous system and no receipt of acupuncture treatment in the past month; 6.Be willing to receive auricular electrical stimulation treatment; 7.Be able to independently and properly operate the vagus nerve stimulation device, and independently complete the treatment manual.
Exclusion criteria
Exclusion criteria: 1.Patients with severe physical illnesses, such as coronary heart disease, malignant tumors, and renal failure; 2.Patients with organic encephalopathy; 3.Patients with any other mental disorders, personality disorders, or psychoactive substance abuse or dependence; 4.Patients who are unable to undergo washout of the drugs mentioned in the inclusion criteria (see Appendix 2) or acupuncture; 5.Pregnant women and lactating women; 6.Patients with auricular skin damage; 7.Patients with an irregular daily routine; 8.Patients deemed unsuitable for participation in this clinical study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in PSQI scores at Week 4 compared with the baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in PSQI scores at Week 2, Week 8, and Week 12 compared with the baseline;The response rates at Week 2, 4, 8, and 12(Definition of response rate: the proportion of patients whose PSQI scores decrease by =50% after treatment compared with the baseline.);The changes in the seven components of PSQI at Week 4, 8, and 12 compared with the baseline;The changes in the Insomnia Severity Index (ISI) scores at Week 2, 4, 8, and 12 compared with the baseline;The changes in the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Epworth Sleepiness Scale (ESS), and Flinders Fatigue Scale (FFS) scores at Week 2, 4, 8, and 12 compared with the baseline; | — |
Countries
China
Contacts
Public ContactShengyuan Yu
Chinese PLA General Hospital
Outcome results
None listed