HRV Biofeedback to Treat Ulcerative Colitis

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05892159

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective interventional study exploring the modifiability of physiological metrics, namely 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Behavioral: HRV biofeedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: HRV biofeedback An HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: HRV biofeedback

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Robert Hirten, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Hirten, Associate Professor, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT05892159

Other Study ID Numbers:

STUDY-21-00870

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Jun 7, 2023