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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT02724800
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years old and older
2. Military Veteran
3. Insomnia Severity Index (ISI) ≥15 \& Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder
4. If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
5. If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
Exclusion Criteria:
1. Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
2. Untreated, current, and severe Major Depressive Disorder as determined by the SCID
3. Current/Past Psychotic or Bipolar disorder
4. Current substance or alcohol use disorder as determined by the SCID
5. Current unstable medical condition
6. Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration
7. Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)
8. Current, untreated, sleep disorders such as nightmare disorder, restless legs syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements as determined by the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake Disorders and/or the STOP-BANG questionnaire
9. Moderate to severe cognitive impairment (St. Louis University Mental Status \[SLUMS\] exam ≤20) and/or diagnosis in medical record indicative of moderate to severe cognitive impairment
10. Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)
11. Pregnancy and/or breast-feeding
STOP-BANG is not a true acronym but indicates the symptoms each item assess:
* S-snores T-tired/sleepy O-observed apneas P-high blood pressure
* B-body mass index A-age N-neck circumference G-gender
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02724800
Study Brief:
Protocol Section:
NCT02724800