Chronic insomnia
Conditions
Interventions
Sham stimulation group:The stimulation of two pair of alternating current of Equal difference-frequency difference
High-frequency difference stimulation group:The stimulation of two pair of alternating current of High-frequency difference
Low-frequency difference stimulation group:The stimulation of two pair of alternating current of Low-frequency difference
Sponsors
Shanghai Geriatric Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18-80 years old; 2. PSQI >=8; 3. Meet the diagnostic criteria for chronic insomnia: insomnia systoms occur at least 3 times per week and persist for at least 3 months; 4. The dosage of sleep and psychotropic medications will be kept constant from two weeks before the study began until its end.
Exclusion criteria
Exclusion criteria: 1. Concomitant with severe organic disease; 2.Concomitant with severe comorbid anxiety or depression, defined by a score of >=21 on the Hamilton Anxiety Rating Scale (HAMA) or >=17 on the 17-item Hamilton Depression Rating Scale. 3. Concomitant with other sleep disorders such as sleep apnea, narcolepsy, restless legs syndrome, or REM sleep behavior disorder; 4. Ineligible for MRI due to implanted metal or electronic devices (e.g., intracranial metal, cochlear implants, non-MRI compatible pacemakers); 5. With implanted cardiac pacemakers or event recorders; 6. With a contraindication to scalp electrode placement due to reasons such as head trauma; 7. Organic brain lesions (such as cerebral hemorrhage, extensive cerebral infarction, encephalitis, epilepsy); 8. Subjects who are currently pregnant, lactating, or intending to conceive during the participation in the study; 9. Subjects who have received physical neuromodulation therapies within the past 30 days, including but not limited to: Electroconvulsive Therapy (ECT), Deep Brain Stimulation (DBS), Transcranial Magnetic Stimulation (TMS), and Vagus Nerve Stimulation (VNS); 10. Subjects currently participating in another interventional trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Fatigue Severity Scales;Reduction in PSQI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Insominia Severity Index;Reduction in Epworth Sleepiness Scale;Reduction in MoCA scale;Change in serum IL-6;Reduction in MAMA scale;Reduction in MMSE scale;Change in serum melatonin and 5-HT levels;Reduction in MAMD scale; | — |
Countries
China
Contacts
Public ContactWeifeng Peng
Shanghai Geriatric Medical Center
Outcome results
None listed