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NCT07647640Recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
9 Jun 2026
Start date
4 Aug 2026
Primary completion date
15 Dec 2027
Lead sponsor
Maastricht University Medical Center
NCT number
NCT07647640

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 4 Aug 2026 to the primary completion date, 15 Dec 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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...

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Maastricht UMC
Coordinator of this site? Confirm its status
MaastrichtNetherlandsRecruiting
Franciscus Hospital
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting
Jeroen Bosch Hospital
Coordinator of this site? Confirm its status
's-HertogenboschNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.