NCT05956158Active, not recruiting
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 28 Nov 2023
- Primary completion date
- 26 Feb 2027
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT05956158
What you commit to
- Study type: Interventional
- Planned participants: 83
- From 28 Nov 2023 to the primary completion date, 26 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current systemic corticosteroid use
Other illness
- Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
- Diagnosis of seizure disorder
- Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
Other
- PHQ-9 depression score ≥ 15
- GAD-7 anxiety score ≥ 15
- Current alcohol or substance abuse
- Current opioid use for pain control
- Current pregnancy or nursing
- Ileostomy or colostomy
- Diagnosis of sleep apnea or positive WatchPAT screen
- Night shift, rotating shift work, or frequent travel outside of time zone
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.