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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05956158
Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate CD based on PRO-3 \& 50% with objective evidence of active disease
* Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes
* Stability of sleep \& CD meds for ≥ 3 months
* Access to internet or cell phone service sufficient for telehealth
Exclusion Criteria:
* PHQ-9 depression score ≥ 15
* GAD-7 anxiety score ≥ 15
* Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
* Current alcohol or substance abuse
* Current opioid 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 WatchPAT screen
* Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
* Night shift, rotating shift work, or frequent travel outside of time zone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05956158
Study Brief:
Protocol Section:
NCT05956158