Clinical Research Directory

TaVNS for Delirium

Sponsor: Stony Brook University

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 hospitalized patients and whether patients and staff can tolerate the treatments. The main questions this study aims to answer are: * Is it possible to deliver taVNS safely and consistently to patients in the hospital who have delirium? * Do patients tolerate the device without significant side effects or complications? 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 hospital. * Be monitored during and after each session. The study team will check vital signs, examine the ear for irritation, and ask about any discomfort. 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 hospitalized 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 hospital 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.

Official title: Transauricular Vagus Nerve Stimulation (taVNS) for Delirium

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