Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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
Qualifiers
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)
Disqualifiers
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...
Trial design
Treatments tested in this trial
- Wearing their own wearable device.
Treatment groups
600 Participants
are divided into 1 treatment groupSponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Maastricht University
Collaborator
TNO
Collaborator
Franciscus Gasthuis & Vlietland (Hospital)
Collaborator
Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
Collaborator
Source ClinicalTrials.gov