Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT06671457
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 65 years;
2. Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
3. Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
4. Insomnia severity as indicated by an ISI score \> 10;
5. Minimum education level of junior high school or above.
Exclusion Criteria:
1. Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
2. Currently using benzodiazepines as sleep aids;
3. Moderate to severe anxiety or depression (HAMD-17 score \> 16 or HAMA score \> 24);
4. Patients with obstructive sleep apnea syndrome;
5. Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
6. Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
7. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
8. Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
9. Severe negative thoughts or high suicide risk;
10. Pregnant or planning to conceive in the near future.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06671457
Study Brief:
Protocol Section:
NCT06671457