RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
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Conditions
Treatments
Details and patient eligibility
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.
Full description
People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, patients with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the investigators want to understand if they can treat sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. If this study is successful, it will help the investigators understand more about how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
83 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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