Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis
Not applicable · Testing HRV biofeedback · Sites not listed yet · Icahn School of Medicine at Mount Sinai
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing HRV biofeedback (a behavioral program) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- Adult subjects (18-65 years old)
- Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC<250µg/ml)
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 23 participants are expected to take part.
- Start date: 2026-06 (planned).
- Main results expected around 2027-04-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Irritable Bowel Syndrome Symptom Severity Scale Score (at end of Week 5)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Enrollment | 23 (estimated) |
| Start date | 2026-06 |
| Primary completion (est.) | 2027-04-30 |
| First posted | 2023-06-07 |
| Last updated | 2026-03-13 |
| Official title | Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT05892159 |
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.
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.