| NCT ID | NCT07258082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stony Brook University |
| Condition | Delirium Treatment |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-09-26 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Isadora Botwinick, MD
PRINCIPAL INVESTIGATOR
Stony Brook University Hospital
Frequently Asked Questions
Who can join the NCT07258082 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Delirium Treatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07258082 currently recruiting?
Yes, NCT07258082 is actively recruiting participants. Contact the research team at isadora.botwinick@stonybrookmedicine.edu for enrollment information.
Where is the NCT07258082 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT07258082 clinical trial?
NCT07258082 is sponsored by Stony Brook University. The principal investigator is Isadora Botwinick, MD at Stony Brook University Hospital. The trial plans to enroll 10 participants.