Chronic Insomnia Disorder
Conditions
Interventions
tDCS real stimulation group:Receive real transcranial direct current stimulation (tDCS)
tDCS sham stimulation group:Receive pseudo-stimulation
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65, any gender; 2. Diagnosed with chronic insomnia disorder by a psychiatrist according to DSM-5 or ICD-10/11; 3. Baseline PSQI total score >= 8; 4. Education level >= 8 years (junior high school or above), able to understand and complete scale assessments; 5. Basic cognitive function normal, MMSE >= 24, MoCA >= 26 (for education <= 12 years, generally up to high school level, 1 point can be added, but total score cannot exceed 30); 6. Adequate visual, olfactory, and auditory abilities to meet cognitive assessment requirements; 7. Agree not to use any other treatments that may affect sleep during the trial, including drug treatments and non-drug treatments (such as cognitive behavioral therapy for insomnia CBT-I, relaxation training, biofeedback, acupuncture, etc.); 8. Obtain written informed consent from the participant and voluntarily participate in this study.
Exclusion criteria
Exclusion criteria: 1. Presence of a severe mental disorder or neurocognitive disorder diagnosed according to DSM-5 or ICD-10/11 (such as schizophrenia spectrum disorder, bipolar disorder, major depression with suicide risk, severe neurocognitive disorder); 2. PSG showing significant sleep-related disorders (such as moderate/severe periodic limb movement disorder), or other sleep disorders that can explain insomnia; 3. Meeting the criteria for a substance use disorder (alcohol, drugs, etc.) in the past 12 months, or having a history of significant substance abuse in the past 6 months; 4. Having severe physical illnesses, such as diagnosed diabetes, hypertension, thyroid disease, heart disease, malignancy, etc.; 5. Presence of medical factors causing chronic physical discomfort (such as chronic pain, itching, etc.); 6. Contraindications to MRI (such as having a pacemaker, non-removable metal implants in the body, etc.); 7. Presence of contraindications to tDCS, such as severe scalp skin disease or open wounds, skull defects, active epilepsy or a history of unprovoked seizures in the past 2 years, intracranial metal implants (such as deep brain stimulation electrodes), etc.; 8. Poor compliance, cannot complete at-home tDCS procedures or follow-up; 9. Pregnant or breastfeeding women, or those planning pregnancy; 10. Participation in other interventional clinical trials in the past 3 months, or previous receipt of transcranial stimulation with severe adverse reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores of Pittsburgh Sleep Quality Index;Scores of Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnography-derived sleep architecture;Scores of Montreal Cognitive Assessment;Scores of Mini-Mental State Examination;Structural MRI, resting-state fMRI, and DTI;Blood IL-6 levels;Blood TNF-a levels;Blood cortisol levels;Blood BDNF levels;Generalized Anxiety Disorder-7;Patient Health Questionnaire-9; | — |
Countries
China
Contacts
Public ContactShi Le
Peking University Sixth Hospital
Outcome results
None listed