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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07431034
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 60 years.
* Meets diagnostic criteria for insomnia disorder according to DSM-5, based on clinical interview or a validated screening procedure.
* Insomnia Severity Index (ISI) score ≥ 10, indicating at least subthreshold insomnia.
* Reports difficulty initiating or maintaining sleep or early-morning awakenings at least three nights per week for at least three months, with associated daytime impairment (e.g., fatigue, concentration problems, irritability).
* Able to read and understand Persian.
* Has regular access to the internet and a smartphone and/or computer to use the Omid web-based program.
* Willing and able to provide informed consent and to complete online questionnaires and daily sleep diaries.
Exclusion Criteria:
* Uncontrolled medical or neurological conditions that significantly interfere with sleep or require immediate treatment (e.g., untreated moderate-to-severe obstructive sleep apnea, uncontrolled epilepsy, unstable cardiac disease, advanced cancer).
* Current shift work or rotating work schedules that regularly disrupt nighttime sleep.
* Pregnancy.
* Participation in another clinical trial or research study that could affect sleep during the study period.
* Ongoing structured psychotherapy specifically targeting insomnia or other major psychiatric conditions within the past 6 months.
* Current major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, psychotic disorders), as determined by clinical assessment or structured interview.
* Evidence of problematic substance use, such as heavy alcohol use (more than approximately 3 standard drinks per day on most days of the month) or frequent misuse of recreational drugs (e.g., cannabis use more than once per week), in the judgment of the investigators.
* Active suicidal ideation or behavior requiring urgent clinical intervention.
* Primary diagnosis of another untreated sleep disorder (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorder) where insomnia is not the main problem.
* Having an infant or child under 2 years of age whose care regularly disrupts nighttime sleep, in the judgment of the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07431034
Study Brief:
Protocol Section:
NCT07431034