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NCT05892159 Clinical Trial

Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05892159
Other study ID # STUDY-21-00870
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date July 2025

Study information
Verified date June 2024
Source Icahn School of Medicine at Mount Sinai
Contact Robert Hirten
Phone 212-241-8100
Email robert.hirten@mountsinai.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective interventional study exploring the modifiability of physiological metrics, namely Heart Rate Variability (HRV), using a 5-week standardized HRV biofeedback intervention in subjects with symptomatic ulcerative colitis. Participants will be followed for 17 weeks. The goal is the understand if modifying these markers can impact ulcerative colitis related symptoms.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 23
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adult subjects (18-65 years old) - Ulcerative colitis with a symptomatic flare (SCCAI =3) and without inflammation (FC<250µg/ml) Exclusion Criteria: - Individuals who take medications known to alter heart rate variability - Individuals with pacemakers or other implantable devices

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• HRV biofeedback
An HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Outcome
Type Measure Description Time frame Safety issue
Primary Irritable Bowel Syndrome Symptom Severity Scale Score Clinical symptom improvement: Improvement in a clinical symptom score. Responders will be classified as those with an Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS; full scale range 0-500, where severe symptoms are = 300) that decreases by = 50 points at the end of week 5. at end of Week 5
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