Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

NCT05892159 | Not Yet Recruiting

• 1 other identifier: STUDY-21-00870
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HRV biofeedback

EXPERIMENTAL

An HRV biofeedback tool will be employed in which individuals will breathe at their resonance frequency to optimize HRV and autonomic nervous system signatures.

Behavioral: HRV biofeedback

Interventions

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.

HRV biofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (18-65 years old)
• Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC\<250µg/ml)

You may not qualify if:

• Individuals who take medications known to alter heart rate variability
• Individuals with pacemakers or other implantable devices

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Robert Hirten

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Hirten

CONTACT

212-241-8100; robert.hirten@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share