Insomnia Disorder
Conditions
Interventions
Group of patients with insomnia and difficulty falling asleep:Individualized and closed-loop transcranial electrical stimulation
Group of patients with insomnia with difficulty maintaining sleep:Individualized and closed-loop transcranial electrical stimulation
Group of patients with insomnia:None
Healthy control group:None
Sponsors
Shanghai Yangzhi rehabilitation hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.For the patients with insomnioa disoder, meet the diagnostic criteria for insomnia as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a confirmed diagnosis of insomnia through the standardized Mini-International Neuropsychiatric Interview (M.I.N.I. 2.For the patients with insomnioa disoder, no use of psychiatric medications within the 8 weeks prior to enrollment or stable use of psychiatric medications during the treatment period; 3.For the patients with insomnioa disoder, no receipt of electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), transcranial electrical stimulation (tES), or cognitive behavioral therapy for insomnia within the 8 weeks prior to enrollment; 4.For healthy participants, conduct scale screening before the experiment begins and thoroughly inquire about medical history to exclude psychiatric disorders such as anxiety, depression, and sleep disorders, as well as organic diseases. All healthy participants must avoid the intake of nicotine, alcohol, caffeine, or other sleep-affecting substances during the experiment; 5.For the both patients with insomnioa disoder and healthy controls , educational level of junior high school or higher; 6. For patients with insomnia and healthy subjects, ages 18-75 years, male:female = 1:1;
Exclusion criteria
Exclusion criteria: 1.Individuals who currently or previously meet the diagnostic criteria for any disorders other than insomnia, anxiety disorders, and depressive disorders as defined in the DSM-5; 2.Severe anxiety or depressive symptoms (HAMD-17 score > 23 or HAMA score > 30); 3.Patients with moderate to severe obstructive sleep apnea syndrome; 4.Patients with migraines; 5.Severe somatic diseases or any somatic conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases; 6.A history of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or brain trauma, or prior brain surgery; 7.Individuals with implanted medical devices such as intracranial stents, pacemakers, coronary stents, or cochlear implants; 8.Presence of severe negative ideation or high suicide risk; 9.Pregnant women or those planning to conceive in the near future;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response;Treatment remission;Side effects scale;Pittsburgh Sleep Quality Index;Beck Anxiety Inventory;Beck Depression Inventory, BDI-II; | — |
Countries
China
Contacts
Public ContactDanmei Lan
Shanghai Yangzhi rehabilitation hospital
Outcome results
None listed