Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05892159
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 7, 2023
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Irritable Bowel Syndrome Symptom Severity Scale Score [ Time Frame: at end of Week 5 ]

Central Contacts

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