NCT07258082 · Stony Brook University
TaVNS for Delirium
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Feasibility of taVNS in hospitalized patients with delirium
Time frame: From enrollment to end of treatment at a maximum of 7 days
We will assess feasibility of taVNS as follows: The proportion of stimulation delivered relative to the stimulation prescribed, calculated as: Stimulation delivered (minutes) /Stimulation prescribed (minutes) Feasibility will be demonstrated if: 1. The mean proportion of stimulation delivered across the cohort is ≥10%. Previous taVNS studies in adults have demonstrated that as little as 6 minutes of stimulation is adequate to demonstrate neuromodulatory effect as detected by fMRI. In our protocol, patients will be prescribed a total of 60 minutes of stimulation per day of study 6 minutes of stimulation (a known minimum effective dose) is thus 10% of prescribed stimulation time. 2. At least 80% of patients achieve ≥10% of prescribed stimulation.
Feasibility of taVNS in delirious hospitalized patients
Time frame: From enrollment to the end of study at a maximum of 7 days
We will assess feasibility of taVNS as follows: The proportion of stimulation delivered relative to the stimulation prescribed, calculated as: Stimulation delivered (minutes) / Stimulation prescribed (minutes) Feasibility will be demonstrated if: 1. The mean proportion of stimulation delivered across the cohort is ≥10%. Previous taVNS studies in adults have demonstrated that as little as 6 minutes of stimulation is adequate to demonstrate neuromodulatory effect as detected by fMRI. In our protocol, patients will be prescribed a total of 60 minutes of stimulation per day of study. 6 minutes of stimulation (a known minimum effective dose) is thus 10% of prescribed stimulation time. 2. At least 80% of patients achieve ≥10% of prescribed stimulation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Stony Brook University Hospital inpatient, Age \> 22
- Right- handed
- Screen positive for delirium on ICDSC instrument
Exclusion criteria
- Severe neurologic disability including severe traumatic brain injury, severe permanent cognitive impairment
- Pacemaker present
- Implanted VNS stimulator present
- Personal history of epilepsy
- Facial or ear pain or trauma
- Recent history of substance abuse
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
- Weight \< 40kg
- Pregnant females
- Intubated patient
Where
- Stony Brook, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations