CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Whoop strap 3.0device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04333810
NCT04333810N/ACompleted

Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study

Milton S. Hershey Medical Center·observational·Posted Apr 3, 2020·Updated Sep 21, 2023

In Brief

An observational study evaluating Whoop strap 3.0 for Inflammatory Bowel Diseases. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Inflammatory bowel disease (IBD) has become a more prominent disease in the US population, with more than 3 million adults in the US affected. To manage this disease effectively, physicians tend to need to have a multidisciplinary approach as there are many psychosocial implications of chronic gastrointestinal illnesses like Crohn's and Ulcerative Colitis. Recent literature has supported the desire for telemedicine and remote physiologic monitoring for such patients to allow the patient to be more active in their treatments and make physicians more aware of what their bodies are doing from a physiologic perspective. Whoop is a new device founded in 2011 that has grown in popularity for its ability to accurately measure sleep patterns, resting heart rate, and heart rate variability (HRV) amongst other various physiologic measurements. Newer literature supports that depressed heart rate variability can correlate to disease flares such as heart failure exacerbations. The study investigators proposed that using remote physiologic monitoring in the IBD population along with their symptoms can help predict disease severity and potentially lead to earlier interventions if correlations are accurate. It can also spark interest in the younger generation for remote physiologic monitoring and telemedicine, which is believed to be beneficial in patients with chronic illnesses.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 3, 2020
Enrollment StartOct 1, 2020
Primary CompletionJul 31, 2022
Study CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.2 years ago

Interventions

Whoop strap 3.0device

WHOOP strap 3.0, a photodiode-based device that tracks sleep duration, resting heart rate, heart rate variability, activity (calories).