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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT05034159
Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate Crohn's disease (as assessed by PRO-3 score)
* Insomnia severity index score of 8 or greater
* Sleep onset latency and/or wake after sleep onset of at least 30 minutes
* Access to device and internet/cell phone service sufficient for telehealth
Exclusion Criteria:
* PHQ-9 score of 20 or greater
* GAD-7 score of 20 or greater
* Unstable major psychiatric condition
* Current alcohol or substance abuse
* Current narcotic use for pain control
* Current systemic corticosteroid use
* Current pregnancy or nursing
* Ileostomy or colostomy
* Diagnosis of seizure disorder
* Diagnosis of sleep apnea or positive STOP-Bang screen
* Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RLSq screen
* Night shift, rotating shift work, or frequent travel outside of primary time zone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05034159
Study Brief:
Protocol Section:
NCT05034159