Chronic Insomnia
Conditions
Interventions
Active-tPCS Group :Real tPCS 12 times, stimulation intensity :0.6mA, 30 minutes each time
Sham-tPCS Group :False stimulation 12 times, only increasing/decreasing the current, for 30 minutes each time
Sponsors
Neurological Disease Center, Chongqing Western Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adult subjects aged between 18~65 years old, male or female; 2. Subject has been diagnosed by a qualified psychiatrist for insomnia, where the diagnosis of insomnia is based on the International Classification of Diseases 10th Revision (ICD-10) criteria, according to subjective and objective sleep disorders; 3. Subject has a score of 11~21 points on the 19-item Pittsburgh Sleep Quality Inventory (PSQI); 4. During the baseline period, the wrist motion recorder (ActiGraph wGT3X-BT) was used for three consecutive nights of monitoring, and the average total sleep time (TST) was <=480 minutes (<=8 hours); 5. Negative pregnancy test (for women with childbearing potential) 6. Subjects must be on stable dose of medication, for at least 30 days prior to screening. Medication and dose adjustments are allowed but must be documented; 7. Able to provide written informed consent and able to comply with study protocol.
Exclusion criteria
Exclusion criteria: 1. Severe anxiety and depressive symptoms that include suicidal behaviors requiring immediate medical attention; 2. Mental illnesses including severe psychosis, bipolar disorder, schizophrenia, and mania; 3. tPCS-specific exclusions included metal in the head, history of neurosurgical procedures, history of seizures or craniotomy, implanted medical or metallic devices (including pacemakers, defibrillators, cochlear implants, deep brain stimulation devices, or ferromagnetic bioimplants), of brain surgery or placement of a deep brain stimulator, pacemaker or defibrillator; 4. Clinically significant functional impairment related to cardiovascular, pulmonary, metabolic, other severe neurological disease; 5. Subjects with other sleep disorders other than insomnia, such as obstructive sleep apnea , periodic limb movement disorder, narcolepsy, parasomnia, or hypersomnia 6. Pregnant women and breast-feeding women; Night shift workers 7. History of heavy alcoholic dependency, caffeine dependency or drug addicts. medical condition that might require other medical or surgical treatment during the study period; 8. Current participation in psychological therapies such as Cognitive Behavioral Therapy (CBT) or in another investigational interventional study; recent history (past 3 months ) of non-invasive brain stimulations eg. rTMS, tDCS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actigraphy Total sleep time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other wrist actigraphy sleep parameters including Sleep Efficiency (SE), Sleep Latency (SL ), Total time in bed (TIB), Wake After Sleep Onset (WASO), Average no. of awakenings, Average awakening time etc;Pittsburgh Sleep Quality Inventory (PSQI);Self-rating Depression (SDS);Self-rating Anxiety (SAS); | — |
Countries
China
Contacts
Public ContactXiaojiang Jiang
Chongqing Western Hospital
Outcome results
None listed