Status:
COMPLETED
Feasibility of Insomnia Tracking and Treatment in IBD
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Inflammatory Bowel Diseases
Insomnia
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study is a longitudinal clinical trial designed to characterize sleep patterns in individuals with Inflammatory Bowel Disease (IBD) as well as to assess the feasibility of sleep intervention (Cog...
Eligibility Criteria
Inclusion
- Inclusion Criteria (IBD Participants):
- Documented IBD
- Mild to moderate Crohn's Disease or Ulcerative Colitis as measured by the Physicians Global Assessment
- Inclusion Criteria (Healthy Participants)
- No personal history of IBD
- No personal history of Irritable Bowel Syndrome (IBS) or Celiac Disease
- No current gastrointestinal symptoms or concerns
- No family history of IBD or Celiac Disease
- Exclusion Criteria (both IBD participants and healthy participants)
- PHQ-9 depression score \> 15
- GAD-7 anxiety score \> 15
- Current alcohol or substance abuse
- Current narcotic use
- Unstable major psychiatric condition
- Current sleep apnea or restless leg syndrome
- Other problems that would interfere with study participation at investigator discretion
Exclusion
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04132024
Start Date
October 7 2019
End Date
April 15 2021
Last Update
May 11 2021
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766-1000