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

NCT ID: NCT05662059

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2023-12-30

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

RAVANS

Intervention Type: DEVICE

Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation

Sham

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

Group Type: SHAM_COMPARATOR

RAVANS-sham

Intervention Type: DEVICE

RAVANS sham device

Interventions

RAVANS

Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation

Intervention Type: DEVICE

RAVANS-sham

RAVANS sham device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

Exclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cala Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Feinstein Institute for Medical Research at Northwell Health

Lake Success, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jillian Charyn

Role: CONTACT

jcharyn@northwell.edu

516-472-3691

Benjamin Sahn, MD

Role: CONTACT

Bsahn@northwell.edu

516-472-3650

Facility Contacts

Jillian Charyn

Role: primary

jcharyn@northwell.edu

516-472-3650

Other Identifiers

IBD-01

Identifier Type: -

Identifier Source: org_study_id