Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study

Starting soon

Conditions studied: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD)

In brief

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.

Key facts

Study ID

NCT07647640

Run by

Maastricht University Medical Center

People needed

600

Starts

2026-06-15

Expected to finish

2027-10-15

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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...

Where it is running

• Jeroen Bosch Hospital — 's-Hertogenbosch, Netherlands
• Maastricht UMC+ — Maastricht, Netherlands
• Franciscus Hospital — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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