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

NCT04333810 | Completed

• 1 other identifier: STUDY14888
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

Remote monitoring; Heart rate variability; Whoop strap 3.0

Outcome Measures

Primary Outcomes (4)

• Inflammatory Bowel Disease flares

  Inflammatory Bowel Disease flares will be assessed by symptomatology and verified by colonoscopic biopsies to confirm active disease, reemergence of disease, or new disease.

  6 months

• Change in Sleep (hours per night)

  Sleep will be objectively measured nightly using the wearable Whoop strap 3.0, and averages will be compared every 2 weeks over the duration of the study.

  6 months, change measured every 2 weeks

• Change in Heart Rate Variability (HRV)

  Heart Rate Variability will be objectively measured nightly using the wearable Whoop strap 3.0. Average two-week values will be assessed for change every 2 weeks over the duration of the study.

  6 months, change measured every 2 weeks

• Change in Resting Heart Rate (RHR)

  Resting Heart Rate will be objectively measured nightly using the wearable Whoop strap 3.0. Average two-week values will be assessed for change every 2 weeks over the duration of the study.

  6 months, change measured every 2 weeks

Study Arms (2)

Active IBD patients

Patients with active IBD, based on colonoscopic evaluation and biopsy results.

Device: Whoop strap 3.0

IBD patients in remission

IBD patients in remission, with no recently colonoscopic evidence of disease, and only on maintenance therapy.

Device: Whoop strap 3.0

Interventions

Whoop strap 3.0 DEVICE

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

Active IBD patients; IBD patients in remission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inflammatory Bowel Disease (IBD) patients at Penn State Milton S. Hershey Medical Center with either active disease or inactive disease (remission) will be enrolled in this study according to the inclusion and exclusion criteria below.

You may qualify if:

• IBD patients at Penn State Milton S. Hershey Medical Center
• Age greater than 18

You may not qualify if:

• Inability to wear Whoop Strap 3.0 for 24 hours per day for 6 months
• Subjects who are pregnant
• Subjects who are on anti-arrhythmic medications
• Subjects who are prisoners

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (15)

• Carson HJ, Dudley MH, Knight LD, Lingamfelter D. Psychosocial complications of Crohn's disease and cause of death. J Forensic Sci. 2014 Mar;59(2):568-70. doi: 10.1111/1556-4029.12314.

  PMID: 24749148 BACKGROUND

• Jones JL, Nguyen GC, Benchimol EI, Bernstein CN, Bitton A, Kaplan GG, Murthy SK, Lee K, Cooke-Lauder J, Otley AR. The Impact of Inflammatory Bowel Disease in Canada 2018: Quality of Life. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S42-S48. doi: 10.1093/jcag/gwy048. Epub 2018 Nov 2.

  PMID: 31294384 BACKGROUND

• Sobolewska-Wlodarczyk A, Wlodarczyk M, Banasik J, Gasiorowska A, Wisniewska-Jarosinska M, Fichna J. Sleep disturbance and disease activity in adult patients with inflammatory bowel diseases. J Physiol Pharmacol. 2018 Jun;69(3). doi: 10.26402/jpp.2018.3.09. Epub 2018 Sep 28.

  PMID: 30279306 BACKGROUND

• Ananthakrishnan AN, Long MD, Martin CF, Sandler RS, Kappelman MD. Sleep disturbance and risk of active disease in patients with Crohn's disease and ulcerative colitis. Clin Gastroenterol Hepatol. 2013 Aug;11(8):965-71. doi: 10.1016/j.cgh.2013.01.021. Epub 2013 Feb 1.

  PMID: 23376797 BACKGROUND

• Swanson GR, Gorenz A, Shaikh M, Desai V, Forsyth C, Fogg L, Burgess HJ, Keshavarzian A. Decreased melatonin secretion is associated with increased intestinal permeability and marker of endotoxemia in alcoholics. Am J Physiol Gastrointest Liver Physiol. 2015 Jun 15;308(12):G1004-11. doi: 10.1152/ajpgi.00002.2015. Epub 2015 Apr 23.

  PMID: 25907689 BACKGROUND

• Jimenez Morgan S, Molina Mora JA. Effect of Heart Rate Variability Biofeedback on Sport Performance, a Systematic Review. Appl Psychophysiol Biofeedback. 2017 Sep;42(3):235-245. doi: 10.1007/s10484-017-9364-2.

  PMID: 28573597 BACKGROUND

• Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.

  PMID: 28478782 BACKGROUND

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 BACKGROUND

• Bullinga JR, Alharethi R, Schram MS, Bristow MR, Gilbert EM. Changes in heart rate variability are correlated to hemodynamic improvement with chronic CARVEDILOL therapy in heart failure. J Card Fail. 2005 Dec;11(9):693-9. doi: 10.1016/j.cardfail.2005.06.435.

  PMID: 16360965 BACKGROUND

• Tsuji H, Larson MG, Venditti FJ Jr, Manders ES, Evans JC, Feldman CL, Levy D. Impact of reduced heart rate variability on risk for cardiac events. The Framingham Heart Study. Circulation. 1996 Dec 1;94(11):2850-5. doi: 10.1161/01.cir.94.11.2850.

  PMID: 8941112 BACKGROUND

• Liu G, Wang L, Wang Q, Zhou G, Wang Y, Jiang Q. A new approach to detect congestive heart failure using short-term heart rate variability measures. PLoS One. 2014 Apr 18;9(4):e93399. doi: 10.1371/journal.pone.0093399. eCollection 2014.

  PMID: 24747432 BACKGROUND

• Riaz MS, Atreja A. Personalized Technologies in Chronic Gastrointestinal Disorders: Self-monitoring and Remote Sensor Technologies. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1697-1705. doi: 10.1016/j.cgh.2016.05.009. Epub 2016 May 14.

  PMID: 27189911 BACKGROUND

• Baars JE, Markus T, Kuipers EJ, van der Woude CJ. Patients' preferences regarding shared decision-making in the treatment of inflammatory bowel disease: results from a patient-empowerment study. Digestion. 2010;81(2):113-9. doi: 10.1159/000253862. Epub 2010 Jan 9.

  PMID: 20093836 BACKGROUND

• Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11.

  PMID: 32043961 BACKGROUND

• Engels M, Cross RK, Long MD. Exercise in patients with inflammatory bowel diseases: current perspectives. Clin Exp Gastroenterol. 2017 Dec 22;11:1-11. doi: 10.2147/CEG.S120816. eCollection 2018.

  PMID: 29317842 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Andrew Tinsley, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: October 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)