Ulcerative ColitisNCT05892159
Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis
A study testing HRV biofeedback in people with Ulcerative Colitis, run by Icahn School of Medicine at Mount Sinai.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- HRV biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (18-65 years old)
- Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC<250µg/ml)
Who cannot join
- Individuals who take medications known to alter heart rate variability
- Individuals with pacemakers or other implantable devices
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis
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.
- Conditions
- Ulcerative Colitis
- Being tested
- HRV biofeedback
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV biofeedbackBehavioural
An HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| HRV biofeedback | Experimental | An HRV biofeedback tool will be employed in which individuals will breathe at their resonance frequency to optimize HRV and autonomic nervous system signatures. Receives: Behavioral: HRV biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at end of Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study startJun 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Hirten, Icahn School of Medicine at Mount Sinai
- Investigators
- Robert Hirten, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892159
- Sponsor's protocol ID
- STUDY-21-00870
- Status last verified
- Mar 2026
- First submitted
- 28 May 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are limitations in our institutional review board approval relating to individual patient level data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05892159
- Acronym / sponsor ID
- STUDY-21-00870
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRV biofeedback | Experimental | Behavioral: HRV biofeedbackAn HRV biofeedback tool will be employed in which individuals will breathe at their resonance frequency to optimize HRV and autonomic nervous system signatures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult subjects (18-65 years old)
- Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC<250µg/ml)
Key exclusion criteria (2 listed)
- Individuals who take medications known to alter heart rate variability
- Individuals with pacemakers or other implantable devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV biofeedbackAn HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period. | Behavioural | HRV biofeedback |
Primary outcome
Irritable Bowel Syndrome Symptom Severity Scale Score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. There are limitations in our institutional review board approval relating to individual patient level data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Hirten principal investigator
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A study testing HRV biofeedback in people with Ulcerative Colitis, run by Icahn School of Medicine at Mount Sinai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Hirten (212-241-8100, robert.hirten@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Symptom Severity Scale Score (time frame: at end of Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.