NCT07647640

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

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

Keywords

Inflammatory Bowel DiseaseDigital biomarkersHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Prediction of mucosal inflammation (assessed by laboratory tests and/or imaging in IBD) using changes in physical activity and sleep metrics relative to individual baseline.

    1 year

  • Identification of a discrepancy between inflammatory flares and symptomatic flares (MIAH-CD>3.6 and MIAH-UC>3.5) regarding HRV.

    1 year

  • To study the inter-device variability in mean HRV metrics (including MESOR, acrophase, amplitude, SDNN, RMSSD), PA and sleep parameters, compared to resting state.

    1 year

  • Investigation of additional digital phenotypes that can be derived from the available (wearable/clinical) data and how these phenotypes differ across relevant subgroups within the study population.

    1 year

  • To study the difference in step count measured by smartwatches compared with smartphones.

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Patients with IBD

≥18 years or older with Crohn's disease or ulcerative colitis, and having a smartwatch (Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available) ) and/or a smartphone.

Device: Wearing their own wearable device.

Interventions

Wearing their own wearable device.DEVICE

Wearing their own wearable device.

Patients with IBD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from MyIBDCoach, IBDream cohort and IBDthuis (Luscii cohort) with ulcerative colitis or Crohn's Disease.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Franciscus Hospital

Rotterdam, Netherlands

Location

Related Publications (7)

  • Leung W, Case L, Jung J, Yun J. Factors associated with validity of consumer-oriented wearable physical activity trackers: a meta-analysis. J Med Eng Technol. 2021 Apr;45(3):223-236. doi: 10.1080/03091902.2021.1893395. Epub 2021 Mar 22.

    PMID: 33750250BACKGROUND

  • Kaplan GG. The global burden of inflammatory bowel disease: from 2025 to 2045. Nat Rev Gastroenterol Hepatol. 2025 Oct;22(10):708-720. doi: 10.1038/s41575-025-01097-1. Epub 2025 Jul 18.

    PMID: 40681759BACKGROUND

  • Bossuyt P, De Nollin I, De Moor T, Trekels G, Maes I, Dewulf G, Pouillon L. Inflammation Is a Large Dataset of Heartbeats, Groceries, Night Rest, and More. Gastroenterology. 2025 Oct;169(5):1085-1086. doi: 10.1053/j.gastro.2025.05.029. Epub 2025 Jun 25. No abstract available.

    PMID: 40578576BACKGROUND

  • de Jong MJ, Boonen A, van der Meulen-de Jong AE, Romberg-Camps MJ, van Bodegraven AA, Mahmmod N, Markus T, Dijkstra G, Winkens B, van Tubergen A, Masclee A, Jonkers DM, Pierik MJ. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1744-1752. doi: 10.1016/j.cgh.2020.04.038. Epub 2020 Apr 23.

    PMID: 32335133BACKGROUND

  • de Jong M, van der Meulen-de Jong A, Romberg-Camps M, Degens J, Becx M, Markus T, Tomlow H, Cilissen M, Ipenburg N, Verwey M, Colautti-Duijsens L, Hameeteman W, Masclee A, Jonkers D, Pierik M. Development and Feasibility Study of a Telemedicine Tool for All Patients with IBD: MyIBDcoach. Inflamm Bowel Dis. 2017 Apr;23(4):485-493. doi: 10.1097/MIB.0000000000001034.

    PMID: 28267047BACKGROUND

  • Hirten RP, Danieletto M, Scheel R, Shervey M, Ji J, Hu L, Sauk J, Chang L, Arnrich B, Bӧttinger E, Dudley J, Keefer L, Sands BE. Longitudinal Autonomic Nervous System Measures Correlate With Stress and Ulcerative Colitis Disease Activity and Predict Flare. Inflamm Bowel Dis. 2021 Oct 18;27(10):1576-1584. doi: 10.1093/ibd/izaa323.

    PMID: 33382065BACKGROUND

  • Hirten RP, Danieletto M, Sanchez-Mayor M, Whang JK, Lee KW, Landell K, Zweig M, Helmus D, Fuchs TJ, Fayad ZA, Nadkarni GN, Keefer L, Suarez-Farinas M, Sands BE. Physiological Data Collected From Wearable Devices Identify and Predict Inflammatory Bowel Disease Flares. Gastroenterology. 2025 May;168(5):939-951.e5. doi: 10.1053/j.gastro.2024.12.024. Epub 2025 Jan 16.

    PMID: 39826619BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • MJ Pierik, Prof. Dr.

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

E Godecharle, MD

CONTACT

+31 43 388 50 65eline.godecharle@maastrichtuniversity.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)