Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

Mount Sinai Health System

Status: Not yet enrolling

Conditions: Ulcerative Colitis

Treatments: Behavioral: HRV biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05892159

STUDY-21-00870

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

HRV biofeedback

Experimental group

Description:

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

Treatment:

Behavioral: HRV biofeedback