NCT07647640 Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
| NCT ID | NCT07647640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-08-04 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2026-08-04 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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...
Contact & Investigator
MJ Pierik, Prof. Dr.
PRINCIPAL INVESTIGATOR
Maastricht UMC
Frequently Asked Questions
Who can join the NCT07647640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07647640 currently recruiting?
Yes, NCT07647640 is actively recruiting participants. Contact the research team at eline.godecharle@maastrichtuniversity.nl for enrollment information.
Where is the NCT07647640 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Maastricht, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT07647640 clinical trial?
NCT07647640 is sponsored by Maastricht University Medical Center. The principal investigator is MJ Pierik, Prof. Dr. at Maastricht UMC. The trial plans to enroll 600 participants.