Insomnia Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of DSM-5 insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; 2. Insomnia symptoms persist for >3 months, >=3 times a week; 3. Age 18-70 years old, right-handed; 4. Pittsburgh Sleep Quality Index (PSQI) scale score >= 8 points, 17-item Hamilton Depression Scale <= 17 points and 14-item Hamilton Anxiety Scale <= 14 points; 5. Have not taken any drugs or substances that act on the nervous system in the past 1 month, and have not received acupuncture treatment; 6. Able to accept the treatment of ear electrical stimulation, and can cooperate with the acquisition of magnetic resonance data; 7. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with serious physical diseases, such as coronary heart disease, malignant tumor, renal failure, etc.; 2. Patients with organic brain diseases; 3. Combining with any other mental disorder, personality disorder or psychoactive substance abuse or dependence; 4. Those who cannot be eluted by using drugs or acupuncture; 5. Pregnant and lactating women; 6. There are contraindications to MRI examination; 7. Those with damaged ear skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index,PSQI;MRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia severity score;17-item Hamilton Depression Scale score;14-item Hamilton Anxiety Scale score;Epworth Sleepiness Scale;Flinders Fatigue Scale; | — |
Countries
China
Contacts
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences