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:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT03493958
Eligibility Criteria:
* INCLUSION CRITERIA:
Participants will be eligible for this study if they:
* Are 18-65 years old
* A score of 10 or higher on the Insomnia Severity Index\*
* Are admitted as a treatment-seeking inpatient on 1SE under protocol 14-AA-0181 (signing both the clinical and research consent)
* Have been inpatient for at least 14 days prior to consent/screening
* Can speak, understand, and write in English
* Are able to comply with study requirements (including ability to access the Internet at least 2x per week)
EXCLUSION CRITERIA:
Participants will be ineligible for this study if they:
* Are pregnant
* Are a prisoner
* Report a physician diagnosis of moderate to severe obstructive sleep apnea (OSA) OR test positive for moderate to severe OSA as documented with an Apnea Hypopnea Index of 15 events/hour based on WatchPAT testing results
* Have irregular sleep schedules that prevent the ability to follow treatment recommendations (i.e. usual bedtimes outside of 8:00 pm to 2:00 am or arising times outside of 4:00 am to 10:00 am)
* Meet SCID-5/DSM-5 criteria for opioid use disorder in the past year
* Meet SCID-5/DSM-5 criteria for severe cocaine use disorder and/or severe cannabis use disorder in the past year
* Meet diagnostic criteria for an unstable or serious psychiatric condition (schizophrenia, bipolar, major depressive disorder not currently in remission) - based on diagnosis from the SCID for DSM-5
* Are participating in any experimental pharmacological intervention study
* Presence of unstable or serious medical/neurologic illness at PI and MAI discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03493958
Study Brief:
Protocol Section:
NCT03493958