insomnia
Conditions
Interventions
Sham stimulation treatment group:Sham stimulation
True stimulus group : transcranial Alternating Current Stimulation
Sponsors
Xuanwu Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Have a Chronic primary insomnia diagnosis based on the DSM-IV-TR and ICD-10 by at least 2 attending physicians or upper level at the time of enrollment; 1.aged 18-65 years old, male or female; 2.having at least three nights of difficulties in falling asleep (Self-report of sleep latency>45 minutes), and/or maintaining sleep (total sleep time 8 points; 4.no intake of anti-insomnia medication 4 weeks before treatment of the trial; 5.having a significant impairment of daytime functioning; 6.not with any other pharmacological or non-pharmacological treatment during the whole trial; agreeing to birth control for female patients ages 18-50 years during the study period; 7.sufficient audio-visual ability to complete the tests required for the trial; 8.understanding all research content and signing the informed consent.
Exclusion criteria
Exclusion criteria: With the presence of any condition listed below is not allowed in enrollment 1. secondary chronic insomnia caused by physical diseases; 2. having psychotic disorders and personality disorders in axis I and II of DSM-IV-TR comfirmed by MINI; 3. a history of or current epilepsy or severe or unstable organic diseases; 4. pregnant, lactation, or planning to become pregnant in the near future; 5. exposure to electroconvulsive therapy, modified electroconvulsive therapy or transcranial magnetic stimulation or other neuromodulation therapies prior to the enrollment; 6. having epileptic seizures, epilepsy, hydrocephalus, acute brain injury and infection, or medical history of CNS neoplasms; 7. impaired skin integrity at electrode placement site or allergy to electrode gel or adhesive; 8. having cochlear implant, cardiac pacemaker, an implanted device (deep brain stimulation) or metal in the brain; 9. participating in any other clinical trial within 1 month; 10. night shift work; 11. having other sleep disorders including sleep apnea, periodic limb movements, parasomnias, hypersomnia; 12. any inappropriate conditions confirmed by researchers to enroll in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| 17 items Hamilton Depression Rating Scale, HAMD-17;HAMA;CGI-S;Clinical impression improvement;adverse event;TESS; | — |
Countries
China
Contacts
Public ContactYuping Wang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed