Chronic insomnia
Conditions
Interventions
Real stimulation group:Cathodal oscillatory direct current stimulation, frequency 1 Hz, current amplitude 2 mA, stimulation for 20 minutes, followed by a 20-minute interval, then another 20 minutes of
Sham stimulation group:Cathodal oscillatory direct current stimulation using sinusoidal alternating current at a frequency of 1 Hz and a current amplitude of 2 mA, applied for only 10 seconds to maint
all other procedures are identical to Group 1.
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. All patients need to meet the requirements of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders issued by the American Psychiatric Association: diagnostic criteria for chronic primary insomnia disorder and depressive disorder – depressive episode in DSM-V; 2. Aged between 18 and 65; 3. Not coexisting with other mental disorders; 4. Right-handed; 5. Those who did not receive drug treatment in the 4 weeks prior to enrollment, or who have been taking antidepressant and insomnia-related drugs stably for more than 4 weeks; 6. The Hamilton Depression Scale score of 24 items is >=20 points, and the total score of the Pittsburgh Sleep Quality Index is >=7 points; 7. The audio-visual proficiency is sufficient to complete the examinations required for the research; 8. The patient or their family member signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Those who had drug or alcohol abuse/dependence within 6 months prior to enrollment; 2.Within the 6 months prior to enrollment, the patient had suffered from other mental illnesses and had other sleep disorders, including sleep apnea, periodic limb movement, and narcolepsy. 3.Those suffering from severe or unstable organic diseases; 4.Those with a score of 3 or above in item 3(suicide) of the 24-item Hamilton Depression Scale; 5.There is a history of cochlear implantation, pacemaker implantation and any intracranial device implantation. Has a history of brain surgery or epilepsy in the past; 6.Pregnant or lactating women; 7.Damage to the integrity of the skin at the electrode placement site or allergy to the electrode gel or adhesive; 8.Night shift workers; 9.Those who have participated in any other clinical trials within one month prior to enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting-state functional magnetic resonance fALFF values and FC values;Reaction time for emotion processing tasks;Hamilton Depression Scale - 24-item scale, Hamilton Anxiety Scale, Montgomery Depression Scale, Pittsburgh Sleep Quality Index Scale, Insomnia Severity Index Scale and Mood Regulation Questionnaire sc;Event-related magnetic fields in task-state magnetoencephalography;The incidence of adverse events and serious adverse events;Pittsburgh Sleep Quality Index (PSQI) scores at 4 weeks post-treatment and 8 weeks post-treatment; | — |
Countries
China
Contacts
Public ContactWang Yuing
Xuanwu Hospital Capital Medical University
Outcome results
None listed