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

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RAVANS
RAVANS-sham
Sponsored by
Cala Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ulcerative Colitis

Eligibility Criteria

10 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Feinstein Institute for Medical Research at Northwell HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

Two therapy sessions (active stimulation) per day for 12 weeks with Treatment device

Two therapy sessions per day for 12 weeks with Sham device (no active stimulation)

Outcomes

Primary Outcome Measures

Clinical Remission
Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the Partial Mayo at week 12

Secondary Outcome Measures

Clinical Responder
Responder rate in treatment vs sham, assessed by greater than or equal to a 2 point reduction in the Partial Mayo score at week 12

Full Information

First Posted
November 30, 2022
Last Updated
March 16, 2023
Sponsor
Cala Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05662059
Brief Title
Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cala Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sham-Controlled
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Two therapy sessions (active stimulation) per day for 12 weeks with Treatment device
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Two therapy sessions per day for 12 weeks with Sham device (no active stimulation)
Intervention Type
Device
Intervention Name(s)
RAVANS
Intervention Description
Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation
Intervention Type
Device
Intervention Name(s)
RAVANS-sham
Intervention Description
RAVANS sham device
Primary Outcome Measure Information:
Title
Clinical Remission
Description
Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the Partial Mayo at week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Responder
Description
Responder rate in treatment vs sham, assessed by greater than or equal to a 2 point reduction in the Partial Mayo score at week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 10-39 years UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies If age 17 years or younger, a PUCAI score of 10-60 A partial Mayo score of 3-6 If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study If on 5-Aminosalicylate, dose must be stable with following parameters: 28 days on oral medication 28 days on or off rectal medication 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 Able and willing to give written informed consent and comply with the requirements of the study protocol. The earbud electrode must fit properly in the prospective subject's left ear Fecal calprotectin of ≥150 during screening period Exclusion Criteria: Expectation to increase corticosteroids and/or immunosuppressive treatment Presence of bowel stricture History of intra-abdominal or perirectal abscess Disease limited to only rectum (ulcerative proctitis) Active treatment with antibiotics Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix) Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine) Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study Any planned surgical procedure requiring general anesthesia within the course of the study Participation in any other Investigational drug and/or treatment currently or planned during the length of the study Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention Pregnancy or Lactation Comorbid disease with high likelihood of requiring corticosteroid use Inability to comply with study and follow-up procedures Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks Individuals with existing skin lesions on the left ear
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jillian Charyn
Phone
516-472-3691
Email
jcharyn@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Sahn, MD
Phone
516-472-3650
Email
Bsahn@northwell.edu
Facility Information:
Facility Name
Feinstein Institute for Medical Research at Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian Charyn
Phone
516-472-3650
Email
jcharyn@northwell.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Sahn, MD

12. IPD Sharing Statement

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

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