Ulcerative ColitisNCT05662059
Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis
A study testing RAVANS in people with Ulcerative Colitis, run by Cala Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 39 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- RAVANS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 15 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 modification of UCDAI 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:
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- 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
Who cannot join
- 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)
- Antibiotic treatment for active infection
- Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research at Northwell Health
Lake Success, New York, 11042
About this study
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
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
- Being tested
- RAVANS, RAVANS-sham
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAVANSDevice
Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation
RAVANS-shamDevice
RAVANS sham device
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Two therapy sessions (active stimulation) per day for 12 weeks with Treatment device Receives: Device: RAVANS |
| Sham | Sham comparator | Two therapy sessions per day for 12 weeks with Sham device (no active stimulation) Receives: Device: RAVANS-sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the modification of ulcerative colitis disease activity index (UCDAI) Score at week 12
Measured: 12 weeks
Secondary outcomes (1)
Clinical Responder
Responder rate in treatment vs sham, assessed by greater than or equal to a 2 point reduction in the modification of UCDAI Score between 0 and 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start12 Jan 2023
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sham-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cala Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662059
- Sponsor's protocol ID
- IBD-01
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes