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NCT07258082 · ClinicalTrials.gov registry record · NA
TaVNS for Delirium
A NA study of Delirium and Delirium Treatment, sponsored by Stony Brook University.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07258082 is a NA study of Delirium and Delirium Treatment that is actively recruiting participants, run by Stony Brook University. The registered enrollment target is 10 participants, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07258082, a NA study of Delirium and Delirium Treatment, is actively recruiting participants, sponsored by Stony Brook University.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 CAM-ICU 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 chec
Conditions Studied
Interventions
- DEVICE Transauricular Vagus Nerve Stimulation
Study Locations (1)
New York
- Stony Brook University Hospital - Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2028-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07258082
The ClinicalTrials.gov registry entry for NCT07258082 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (99% lower). The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Delirium appearing as the primary indexed condition, and to 1 intervention - of which Transauricular Vagus Nerve Stimulation is the first listed.
NCT07258082 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07258082 about?
NCT07258082 is a clinical study titled "TaVNS for Delirium". 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 ...
What is the current status of trial NCT07258082?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-09-26. Estimated completion is 2028-10.
What conditions does trial NCT07258082 study?
This clinical trial studies the following conditions: Delirium, Delirium Treatment.
What interventions are being tested in trial NCT07258082?
The interventions under investigation include: Transauricular Vagus Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT07258082?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07258082 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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