RISE: A Remote Study of Insomnia Treatment in Crohn's Disease

Running, not enrolling · Not applicable

Conditions studied: Insomnia, Crohn Disease

In brief

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.

Key facts

Study ID

NCT05956158

Run by

Dartmouth-Hitchcock Medical Center

People needed

83

Starts

2023-11-28

Expected to finish

2027-02-28

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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