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

NCT07647640 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Maastricht University Medical Center

Phase

Observational

Started

2026-06-15

Last updated

2026-06-29

Condition(s) studied

Inflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)Crohn Disease (CD)

Investigational drug(s) / intervention(s)

Wearing their own wearable device.

Wearing their own wearable device.: Wearing their own wearable device.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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...

Primary outcome measure(s)

Prediction of mucosal inflammation (calprotectin≥250 µg/g and/or CRP≥5mg/l with UCEIS≥1 or Mayo≥1 (UC) and SES CD≥3 (CD) on endoscopic/radiological evaluation) using HRV-changes relative to individual baseline. — 1 year

Trial sites (3)

Facility	City	Region
Jeroen Bosch Hospital	's-Hertogenbosch	Netherlands
Maastricht UMC+	Maastricht	Netherlands
Franciscus Hospital	Rotterdam	Netherlands

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Other trials for the same condition

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A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC) Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07647640 on ClinicalTrials.gov ↗ ← All trials in the Netherlands