Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

NCT ID: NCT05892159

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HRV biofeedback

Intervention Type BEHAVIORAL

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

Interventions

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HRV biofeedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Robert Hirten

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Hirten

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Central Contacts

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Robert Hirten

Role: CONTACT

212-241-8100

Other Identifiers

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STUDY-21-00870

Identifier Type: -

Identifier Source: org_study_id

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