Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

NCT05892159 — Not applicable, Not yet recruiting, 23 participants, Icahn School of Medicine at Mount Sinai

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Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis

Registry	NCT05892159
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	23 (Estimated)
Sponsor	Icahn School of Medicine at Mount Sinai (Other)
Conditions	Ulcerative Colitis
Interventions	HRV biofeedback (Behavioral)
Dates	start 2026-06-01 (estimated), primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2023-06-07, last updated 2026-03-13

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
HRV biofeedback	Experimental	Behavioral: 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.

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.

+Outcome measures

Primary outcomes

Irritable Bowel Syndrome Symptom Severity Scale Score [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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Investigators

Robert Hirten, Principal investigator, Icahn School of Medicine at Mount Sinai