TaVNS for Delirium

Summary

The goal of this clinical trial is to test whether a non-invasive device called transauricular vagus nerve stimulation (taVNS) is safe, practical, and potentially helpful for patients in the hospital who develop delirium. Delirium is a state of confusion that often happens to people in the hospital who are sick or hurt. It can cause agitation, trouble paying attention and difficulty understanding what is happening. Delirium may slow overall recovery.

This study will focus on feasibility and safety. Researchers want to learn whether taVNS can be given safely to critically-ill patients, whether patients and staff can tolerate the treatments, and whether the device produces measurable changes in brain activity and brain oxygen levels.

The main questions this study aims to answer are:

* Is it possible to deliver taVNS safely and consistently to patients in the ICU who have delirium?
* Do patients tolerate the device without significant side effects or complications?
* Does taVNS cause short-term changes in brain signals and oxygen levels that may suggest effects on brain function? This is an early feasibility study and there is no randomization or placebo group. All patients enrolled will receive taVNS in addition to their usual hospital care for delirium.

What participants will do:

* Be identified by their hospital care team and have a confirmed diagnosis of delirium.
* Provide consent (or have a legally authorized representative provide consent if the patient cannot.)
* Undergo brief assessments of thinking and attention (for example, the ICDSC test.)
* Receive taVNS treatment using a small clip electrode placed on the ear.

* The device sends gentle electrical pulses to the nerve in the ear.
* Each session lasts about 30 minutes, given twice per day (morning and evening, with at least 6 hours between sessions).
* Treatment can continue for up to 7 days while the patient is in the ICU.
* Be monitored during and after each session. The study team will check vital signs, examine the ear for irritation, and ask about any discomfort.
* On the first day, researchers will also record brain signals (EEG) and brain oxygen levels before and during stimulation using FDA-approved hospital monitoring devices.

Possible risks and discomforts:

* Mild side effects are possible, such as tingling, a tickling or pricking feeling in the ear, or temporary skin redness where the clip is placed.
* Serious side effects are not expected, but all patients will be closely monitored during and after each session to ensure safety.

Possible benefits:

• Patients may or may not experience personal benefit. The main benefit is helping researchers learn whether this treatment approach is safe and practical. In the future, taVNS could potentially become a new tool to help treat or prevent delirium in hospitalized patients.

Study size and duration:

* The study will enroll a limited number of ICU patients with delirium at Stony Brook University Hospital.
* Patients may take part for up to 7 days while hospitalized.

Who can join:

* Right-handed, adult patients in the ICU who are diagnosed with delirium.
* People with certain medical conditions (such as brain bleeds, new strokes, pacemakers or other contraindications) may not be able to participate, for safety reasons.

Conditions

• Delirium Treatment
• Delirium

Interventions

DEVICE

Transauricular Vagus Nerve Stimulation

TaVNS starts within 24 hours of consent and is given twice daily (\~30 minutes per session, ≥6 hours apart) for up to 7 days or until delirium resolves. Stimulation will be delivered to the tragus of the left ear via non-invasive clip-on electrode. Stimulation parameters will be set to: pulse width 500 µs, frequency 25 Hz, 30 s on / 30 s off. Current amplitude will be titrated to perceptual threshold (0.5-5.0 mA); if patients are unable to participate in perceptual threshold titration, then 0.6 mA will be utilized. On the first day of stimulation, patients will undergo 10 minutes of baseline EEG and cerebral oximetry, followed by 10 minutes of EEG and cerebral oximetry during taVNS.

Sponsors & Collaborators

• Stony Brook University

  lead OTHER

Principal Investigators

• Isadora Botwinick, MD · Stony Brook University Hospital

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-26

Primary Completion

2028-10-31

Completion

2028-10-31

FDA Device

Yes

Countries

• United States

Study Locations