Clinical trial NCT05956158: RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Official title: RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Crohn Disease
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention as measured by attrition rate over time
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
measure: Feasibility of the intervention as measured by recruitment rate over time
timeFrame: From study initiation until we are no longer actively recruiting (approximately 24 months)
measure: Feasibility of the intervention as measured by assessment completion at multiple time points
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
measure: Feasibility of the intervention as measured by qualitative interviews
timeFrame: 8 weeks and 34 weeks
measure: Acceptability of the intervention as measured by visit completion
timeFrame: 8 weeks
measure: Treatment acceptability questionnaire score
timeFrame: 1 week
measure: Acceptability of the intervention as measured by qualitative interviews
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in insomnia symptoms as measured by the Insomnia Severity Index
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
measure: Change in diary-based sleep onset latency
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
measure: Change in diary-based wake after sleep onset
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
measure: Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
Other outcomes:
measure: Change in C-reactive protein
timeFrame: Baseline, 8 weeks, and 21 weeks
measure: Change in fecal calprotectin
timeFrame: Baseline, 8 weeks, and 21 weeks
measure: Change in sleep architecture
timeFrame: Baseline, 8 weeks, and 21 weeks
measure: Change in behaviorally assessed pain tolerance via the Cold Pressor Test
timeFrame: Baseline, 8 weeks, and 21 weeks
measure: Change in diary-based sleep efficiency
timeFrame: Baseline, 8 weeks, 21 weeks, and 34 weeks
measure: Change in objective sleep onset latency
timeFrame: Baseline, 8 weeks, and 21 weeks
measure: Change in objective wake after sleep onset
timeFrame: Baseline, 8 weeks, and 21 weeks
measure: Change in objective sleep efficiency
timeFrame: Baseline, 8 weeks, and 21 weeks
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: