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NCT07647640
Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Conditions: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 600
Sponsor: Maastricht University Medical Center
Location: Jeroen Bosch Hospital 's-Hertogenbosch
Summary
The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.
Eligibility Criteria
Inclusion Criteria:
* 18 years or older
* Crohn's Disease or ulcerative colitis
* Having a smartwatch and/or a smartphone
* Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)
Exclusion Criteria:
* No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...
Source: ClinicalTrials.gov (NCT07647640). StuddyBuddy aggregates publicly available trial information.
