An interventional study of Transauricular Vagus Nerve Stimulation in Delirium, sponsored by Stony Brook University. Active, not recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Stony Brook University · Not applicable, Interventional, and Device feasibility
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:
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:
Receive taVNS treatment using a small clip electrode placed on the ear.
Possible risks and discomforts:
Possible benefits:
Study size and duration:
Who can join:
This will be a single-arm, open-label trial to assess the feasibility and safety of transauricular vagus nerve stimulation (taVNS) in this population.
Participants enrolled in the optional EEG substudy would undergo 10 minutes of prestimulation EEG and cerebral oximetry, followed by an additional 10 minutes of monitoring during the first taVNS session.
This is an early feasibility study and there is no randomization or placebo group.
All patients enrolled will receive taVNS in addition to usual hospital care for delirium. We aim to recruit 10 patients. Patients will be recruited from an inpatient population in the ICU or hospital unit. Candidates will be identified on daily rounds by a primary medical team. A diagnosis of delirium will be confirmed by a physician trained in psychiatry, neurology or neurocritical care. After inclusion and exclusion are reviewed, a baseline assessment of delirium through the ICDSC (Intensive Care Delirium Screening Checklist) will be completed if one has not already been performed as part of usual clinical care. After screening and informed consent, the patient will be considered as entered into the study. The patient will begin taVNS within 24 hours of enrollment. Patients who are consented but do not begin taVNS within 24 hours will require repeat screening to evaluate updates to clinical condition and repeat ICDSC score to ensure they continue to meet inclusion criteria.
We anticipate that in most situations, a legally authorized representative for the patient will be the initial contact for the study as well as the individual providing consent to the study. If a patient were to meet exclusion criteria after enrollment, they would be ineligible for further participation. Previously collected data prior to the event would still be used for analysis.
The study device is the Soterix Medical Transcutaneous auricular Vagus Nerve Stimulator, for which we have submitted an IDE to the FDA and received nonsignificant risk designation (NSR). The device will be configured with the Soterix Medical RELIfit-Tragus accessory to hook around the ear to deliver stimulation to the auricular branch of the vagus nerve in the tragus of the left ear. TaVNS will be performed on the left side to minimize the already negligible risk of cardiac side effects. The device will be set to a frequency of 25 Hz and pulse width of 500 μs based on previous literature. The intensity will be titrated in the first session. Patients unable to cooperate with the titration procedure will have their stimulation intensity set at 0.6 mA.
Vitals, relevant medical history, labs and medication data will be collected from the medical record.
Subjects will be prescribed two 30-minute sessions of taVNS stimulation each day with a minimum of 6 hours between sessions until delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurs first.
Upon discontinuation of the study, we will screen the subject for any sensory changes, discomfort, or adverse events, as well as perform an additional ICDSC screen. The subject will be discharged without research follow-up due to the minimal risk in the study. Risks and adverse events associated with use of the Soterix Medical Transcutaneous auricular Vagus Nerve Stimulator are small. We ensure patients use the device only under supervision by the research team, with proper application, and perform regular skin inspections after each stimulation session. Subjects will be supervised during monitoring by study personnel who will observe for any evidence of subject discomfort from monitoring. A member of the study team who is a Stony Brook University Hospital ICU attending intensivist will be present throughout each stimulation session, as well as for the initial device intensity titration. A review of pre- and post-session relevant clinical data (including vitals, medications, skin inspection and labs) will be performed.
All enrolled patients who receive at least one session of taVNS will be included in the final analysis. Patients with incomplete data will be reported and analyzed using available data only, without imputation.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's enrollment of 10 is below the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Stony Brook University is the lead sponsor of 197 studies on the registry; 36 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hospitalized, right-hand-dominant adults (age ≥ 22) with delirium, receive transauricular vagus nerve stimulation (taVNS) in addition to standard clinical management. TaVNS is administered twice a day, until delirium resolves, the participant is discharged from the hospital, the participant develops an exclusion criterion, or 7 days are completed, whichever occurs first.
Device: Transauricular Vagus Nerve Stimulation
TaVNS starts within 24 hours of consent and is given twice daily (\~30 minutes per session, ≥6 hours apart) until delirium resolves, the participant is discharged from the hospital, the participant develops an exclusion criterion, or 7 days are completed, whichever occurs first. 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 during the first session (0.5-5.0 mA); if patients are unable to participate in titration, then 0.6 mA will be utilized. On the first day of stimulation, patients in the optional EEG substudy will undergo 10 minutes of baseline EEG and cerebral oximetry, followed by 10 minutes of EEG and cerebral oximetry during taVNS.
Percentage of Prescribed taVNS Stimulation Time Delivered
For each participant, feasibility was calculated as minutes of stimulation delivered divided by minutes of stimulation prescribed while eligible, multiplied by 100. Eligibility ended upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.
Time frame: From enrollment through the end of study participation, which occurred upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.
Number of Participants Receiving ≥10% of Prescribed Stimulation Time
The number of participants who received at least 10% of the taVNS stimulation time prescribed while they remained eligible was reported. Eligibility ended upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.
Time frame: From enrollment through the end of study participation, which occurred upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.
Participants were enrolled between September 2025 and July 2026.
| Milestone | Transauricular Vagus Nerve Stimulation |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Discontinued by investigator for clinical concern unrelated to study procedures | 1 |
For each participant, feasibility was calculated as minutes of stimulation delivered divided by minutes of stimulation prescribed while eligible, multiplied by 100. Eligibility ended upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.
| % of prescribed taVNS stimulation time | Transauricular Vagus Nerve Stimulation |
|---|---|
| Percentage of Prescribed taVNS Stimulation Time Delivered | 100 (100 to 100) |
The number of participants who received at least 10% of the taVNS stimulation time prescribed while they remained eligible was reported. Eligibility ended upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.
| Participants | Transauricular Vagus Nerve Stimulation |
|---|---|
| Number of Participants Receiving ≥10% of Prescribed Stimulation Time | 10 (100 to 100) |
Collected over From enrollment through the end of study participation, which occurred upon delirium resolution, hospital discharge, development of an exclusion criterion, or completion of 7 days, whichever occurred first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transauricular Vagus Nerve Stimulation | 0/10 (0%) | 1/10 (10%) | 4/10 (40%) |
| Event | Transauricular Vagus Nerve Stimulation |
|---|---|
| Acute-on-chronic respiratory failure requiring intubationRespiratory, thoracic and mediastinal disorders | 1/10 |
| Event | Transauricular Vagus Nerve Stimulation |
|---|---|
| Acute gout flareMusculoskeletal and connective tissue disorders | 1/10 |
| Suspected septic bursitisInfections and infestations | 1/10 |
| Gross hematuriaRenal and urinary disorders | 1/10 |
| Emesis/vomitingGastrointestinal disorders | 1/10 |
| Age, Continuous(years) | Transauricular Vagus Nerve Stimulation |
|---|---|
| Median | 79.5 (62 to 93) |
| Sex: Female, Male(Participants) | Transauricular Vagus Nerve Stimulation |
|---|---|
| Female | 6 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Transauricular Vagus Nerve Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Ethnicity (NIH/OMB)(Participants) | Transauricular Vagus Nerve Stimulation |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Sep 2025 to primary completion in Jul 2026, 9 months.
Results were first posted in Oct 2026, 3 months after primary completion.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 9 months is below that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Oct 2028 → Jul 2026 and completion Oct 2028 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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