Cure8 trial brief
Sleep problems are common in Crohn’s disease and may worsen symptoms, pain, and inflammation. This trial is testing whether a remotely delivered insomnia treatment is feasible and whether improving sleep could also improve Crohn’s-related outcomes.
Adults with Crohn’s disease who have insomnia, sleep health researchers, clinical teams managing IBD symptoms, and trialists planning remote behavioral interventions.
This is a registered interventional clinical trial (RISE; NCT05956158) testing remote behavioral insomnia treatment versus sleep education for adults with Crohn’s disease who also have insomnia.
The study is designed as a feasibility trial with outcomes focused on recruitment, retention, assessment completion, visit completion, and qualitative feedback; it will also track symptom and inflammation changes over time but is not positioned as a definitive efficacy trial.
Participants must have mild-to-moderate Crohn’s disease, meet insomnia severity thresholds, and have stable sleep and Crohn’s medications. Key exclusions include moderate-severe depression or anxiety, current opioid or systemic steroid use, certain sleep disorders, pregnancy/nursing, and recent shift-work or frequent travel.
The intervention is delivered remotely at Dartmouth-Hitchcock and plans to enroll about 83 people. If successful, the investigators expect this work to inform whether treating insomnia remotely is practical in Crohn’s patients and to guide future studies on whether improving sleep affects pain and inflammation.
This is a feasibility (early-stage) interventional study focused on whether the trial procedures and remote insomnia treatments can be delivered and assessed in Crohn’s patients. It is not a large definitive trial of clinical effectiveness; planned enrollment is ~83 and primary outcomes are feasibility metrics.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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