Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis
Overview
- Phase
- Not Applicable
- Intervention
- HRV biofeedback
- Conditions
- Ulcerative Colitis
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 23
- Primary Endpoint
- Irritable Bowel Syndrome Symptom Severity Scale Score
- Status
- Not yet recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
Robert Hirten
Associate Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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
Arms & Interventions
HRV biofeedback
An HRV biofeedback tool will be employed in which individuals will breathe at their resonance frequency to optimize HRV and autonomic nervous system signatures.
Intervention: HRV biofeedback
Outcomes
Primary Outcomes
Irritable Bowel Syndrome Symptom Severity Scale Score
Time Frame: at end of Week 5
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.