Inflammatory Bowel Diseases Clinical Trial
Official title:
Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study
NCT number | NCT04333810 |
Other study ID # | STUDY14888 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | July 31, 2023 |
Verified date | September 2023 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - IBD patients at Penn State Milton S. Hershey Medical Center - Age greater than 18 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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