Remote treatment for insomnia in Crohn's disease patients
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
NA · Dartmouth-Hitchcock Medical Center · NCT05956158
This study is testing whether treating insomnia through online sessions can help people with Crohn's disease feel better by improving their sleep and reducing symptoms like pain and inflammation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center (other) |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT05956158 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of treating insomnia in individuals with Crohn's disease and to explore whether improving sleep can alleviate associated symptoms such as pain and inflammation. Participants will receive behavioral treatment and sleep education through telehealth, allowing for remote participation. The study focuses on patients with mild to moderate Crohn's disease who also experience insomnia, with the goal of understanding the relationship between sleep quality and disease management. By addressing sleep issues, the researchers hope to improve overall health outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals with mild to moderate Crohn's disease who experience insomnia and have stable medication regimens.
Not a fit: Patients with severe psychiatric conditions, substance abuse issues, or specific sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of insomnia in Crohn's disease patients, potentially reducing disease flares and enhancing overall quality of life.
How similar studies have performed: While the specific approach of treating insomnia in Crohn's disease is novel, previous studies have shown that addressing sleep issues can improve outcomes in patients with other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Crohn Disease