Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Netherlands
Jeroen Bosch Hospital
RECRUITING
's-hertogenbosch
Maastricht UMC+
RECRUITING
Maastricht
Franciscus Hospital
NOT_YET_RECRUITING
Rotterdam
Contact Information
Primary
E Godecharle, MD
eline.godecharle@maastrichtuniversity.nl
+31 43 388 50 65
Time Frame
Start Date: 2026-08-04
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 600
Treatments
Patients with IBD
≥18 years or older with Crohn's disease or ulcerative colitis, and having a smartwatch (Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available) ) and/or a smartphone.
Related Therapeutic Areas
Sponsors
Collaborators: Jeroen Bosch Ziekenhuis, s'-Hertogenbosch, TNO, Maastricht University, Franciscus Gasthuis & Vlietland (Hospital)
Leads: Maastricht University Medical Center