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HRV Biofeedback to Treat Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HRV biofeedback
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HRV biofeedback

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2023
    Last Updated
    May 28, 2023
    Sponsor
    Icahn School of Medicine at Mount Sinai
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05892159
    Brief Title
    HRV Biofeedback to Treat Ulcerative Colitis
    Official Title
    Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Icahn School of Medicine at Mount Sinai

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    23 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRV biofeedback
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HRV biofeedback
    Intervention Description
    An HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period.
    Primary Outcome Measure Information:
    Title
    Irritable Bowel Syndrome Symptom Severity Scale Score
    Description
    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.
    Time Frame
    at end of Week 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Hirten
    Phone
    212-241-8100
    Email
    robert.hirten@mountsinai.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Hirten
    Organizational Affiliation
    Icahn School of Medicine at Mount Sinai
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There are limitations in our institutional review board approval relating to individual patient level data sharing.

    Learn more about this trial

    HRV Biofeedback to Treat Ulcerative Colitis

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