Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis
Not Applicable
Not yet recruiting
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT05892159
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method