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

NCT07647640 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-06-29

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

Wearing their own wearable device.

Wearing their own wearable device.

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • TNO

    collaborator OTHER

  • Franciscus Gasthuis & Vlietland (Hospital)

    collaborator OTHER

  • Jeroen Bosch Ziekenhuis, s'-Hertogenbosch

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • MJ Pierik, Prof. Dr. · Maastricht UMC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-10-15
Completion
2027-10-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647640 on ClinicalTrials.gov