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NCT Number: NCT05892159

Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV Biofeedback

Behavioral

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

Primary outcomes

  1. 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.

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Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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