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Active Not Recruiting
NCT05956158
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Conditions: Insomnia, Crohn Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 83
Sponsor: Dartmouth-Hitchcock Medical Center
Location: Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Summary
The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.
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
Source: ClinicalTrials.gov (NCT05956158). StuddyBuddy aggregates publicly available trial information.