Insomnia Disorder
Conditions
Interventions
Active tDCS group:Individualized and high-dose transcranial direct current stimulation (tDCS)
Sham tDCS group:None
Sponsors
Shanghai Yangzhi rehabilitation hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree to sign the informed consent form; 2. Promise to abide by the research procedures and cooperate with the implementation of the whole process of research; 3. Age 18-75 years old; 4. Diagnosis of chronic insomnia (according to DSM-5 criteria); 5. Have the ability to take care of themselves and have no drug abuse; 6. Have not received ECT, rTMS, tES therapy, or cognitive behavioral therapy for insomnia within 8 weeks prior to enrollment; 7. If the patient is taking sedative-hypnotic drugs, there is no drug type and dose adjustment within 8 weeks before enrollment
Exclusion criteria
Exclusion criteria: 1. Previous or current diagnosis of other diseases other than insomnia, anxiety disorders and depressive disorders in DSM-5; 2. Severe anxiety or depressed mood (HAMD-17>23 points or HAMA>30 points); 3. Patients with severe obstructive sleep apnea syndrome; 4. Patients with severe migraine who have migraine attacks for two consecutive months >=4 times/month; 5. Serious physical illness and any physical disease that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases; 6. History of neurological diseases (such as epilepsy, cerebrovascular accident, etc.) or traumatic brain injury or brain surgery; 7. Intracranial stents, pacemakers, coronary stents, cochlear implants and other human implantable materials are installed; 8. Having serious negative thoughts or a high risk of suicide; 9. Women who are pregnant or have recently tried to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;Beck Depression Inventory, BDI-II;Beck Anxiety Inventory;Treatment response;Treatment remission;Subjective Sleep Quality;Objective Sleep Quality;Objective Sleep Quality in home;Side effects scale;Epworth Sleepiness Scale; | — |
Countries
China
Contacts
Public ContactDanmei Lan
Shanghai Yangzhi rehabilitation hospital
Outcome results
None listed