Ulcerative Colitis
Conditions
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.
Interventions
BEHAVIORALHRV biofeedback
An HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTRobert Hirten
PRINCIPAL_INVESTIGATORRobert Hirten
Icahn School of Medicine at Mount Sinai
Outcome results
None listed