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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at end of Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Hirten | Contact | 212-241-8100 | robert.hirten@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Hirten | Icahn School of Medicine at Mount Sinai | Principal Investigator |
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There are limitations in our institutional review board approval relating to individual patient level data sharing.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |