RECRUITING

Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, single-center, sham-controlled, double-blinded 12-week study designed to evaluate the safety and efficacy of the RAVANS device in subjects with Ulcerative Colitis. The goal of the study is to distinguish sham (no stimulation) versus treatment (stimulation) response and to identify treatment responders. The study will last 12 weeks with in-clinic visits at 0 weeks and 12 weeks, and a telehealth-visit at week 6. Additionally, unscheduled visits may occur based on the needs of the subject or at the discretion of the investigator. Subjects will be randomized 2:1 to treatment or sham, and will stimulate at home twice per day.

Official Title

Investigating the Safety and Efficacy of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) in Ulcerative Colitis (UC) in Pediatric and Young Adult Populations

Quick Facts

Study Start:2023-01-12

Study Completion:2023-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05662059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 10-39 years 2. UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies 3. If age 17 years or younger, a PUCAI score of 10-60 4. A partial Mayo score of 3-6 5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study 6. If on 5-Aminosalicylate, dose must be stable with following parameters: * 28 days on oral medication * 28 days on or off rectal medication 7. If on background immunosuppressive treatment the dose must be stable with the following parameters: * 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine) * 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic, tofacitinib, upadacitinib, ozanimod 8. Able and willing to give written informed consent and comply with the requirements of the study protocol. 9. The earbud electrode must fit properly in the prospective subject's left ear 10. Fecal calprotectin of ≥150 during screening period	1. Expectation to increase corticosteroids and/or immunosuppressive treatment 2. Presence of bowel stricture 3. History of intra-abdominal or perirectal abscess 4. Disease limited to only rectum (ulcerative proctitis) 5. Active treatment with antibiotics 6. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks 7. Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix) 8. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. 9. Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine) 10. Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study 11. Any planned surgical procedure requiring general anesthesia within the course of the study 12. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study 13. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention 14. Pregnancy or Lactation 15. Comorbid disease with high likelihood of requiring corticosteroid use 16. Inability to comply with study and follow-up procedures 17. Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks 18. Individuals with existing skin lesions on the left ear

Inclusion Criteria

Exclusion Criteria

1. Age 10-39 years
2. UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies
3. If age 17 years or younger, a PUCAI score of 10-60
4. A partial Mayo score of 3-6
5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
6. If on 5-Aminosalicylate, dose must be stable with following parameters:
* 28 days on oral medication
* 28 days on or off rectal medication
7. If on background immunosuppressive treatment the dose must be stable with the following parameters:
* 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
* 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic, tofacitinib, upadacitinib, ozanimod
8. Able and willing to give written informed consent and comply with the requirements of the study protocol.
9. The earbud electrode must fit properly in the prospective subject's left ear
10. Fecal calprotectin of ≥150 during screening period

1. Expectation to increase corticosteroids and/or immunosuppressive treatment
2. Presence of bowel stricture
3. History of intra-abdominal or perirectal abscess
4. Disease limited to only rectum (ulcerative proctitis)
5. Active treatment with antibiotics
6. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
7. Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix)
8. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
9. Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine)
10. Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study
11. Any planned surgical procedure requiring general anesthesia within the course of the study
12. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
13. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
14. Pregnancy or Lactation
15. Comorbid disease with high likelihood of requiring corticosteroid use
16. Inability to comply with study and follow-up procedures
17. Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks
18. Individuals with existing skin lesions on the left ear

Contacts and Locations

Study Contact

Jillian Charyn

CONTACT

516-472-3691

jcharyn@northwell.edu

Benjamin Sahn, MD

CONTACT

516-472-3650

Bsahn@northwell.edu

Study Locations (Sites)

Feinstein Institute for Medical Research at Northwell Health

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Cala Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-12

Study Completion Date2023-12-30

Study Record Updates

Study Start Date2023-01-12

Study Completion Date2023-12-30

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis