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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT06614803
Eligibility Criteria:
Inclusion Criteria:
1. Age over 18 years;
2. Meet the definition of insomnia in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V)；
3. Has not received any psychotropic drug treatment；
4. PSQI(Pittsburgh Sleep Quality Index) score\>7；
5. ISI(Insomnia Severity Index) score≥11；
6. Signed informed consent form;
7. Ability and willingness to comply with the study requirements.
Exclusion Criteria:
1. There are learning or working hours that affect the circadian rhythm;
2. There is abuse of alcohol, nicotine, or other substances;
3. Pregnancy, breastfeeding, or plans to become pregnant;
4. Damage or allergy to the selected stimulation site;
5. Clinically diagnosed mental disorders and other medical conditions;
6. Currently taking stimulant, hormone, or other medications that may cause insomnia and are not suitable for discontinuation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
28 Years
Study:
NCT06614803
Study Brief:
Protocol Section:
NCT06614803