Actively Recruiting
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Led by Dartmouth-Hitchcock Medical Center · Updated on 2025-10-31
83
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mild to moderate Crohn's disease based on PRO-3 and 50% with objective evidence of active disease
- Insomnia Severity Index score of 8 or higher and sleep onset latency or wake after sleep onset of 30 minutes or more
- Stable sleep and Crohn's disease medications for 3 months or longer
- Access to internet or cell phone service sufficient for telehealth
You will not qualify if you...
- PHQ-9 depression score of 15 or higher
- GAD-7 anxiety score of 15 or higher
- Unstable major psychiatric condition such as bipolar disorder or psychotic disorder
- Current alcohol or substance abuse
- Use of opioids for pain control
- Use of systemic corticosteroids
- Current pregnancy or nursing
- Having an 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
- Working night shifts, rotating shifts, or frequent travel across time zones
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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