Delirium TreatmentNCT07258082
TaVNS for Delirium
A study testing Transauricular Vagus Nerve Stimulation in people with Delirium Treatment and Delirium, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Delirium Treatment, Delirium
- What is being tested?
- Transauricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stony Brook University Hospital inpatient, Age > 22
- Right- handed
- Screen positive for delirium on ICDSC instrument
Who cannot join
- 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
Show all 10Show fewer
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
- Weight < 40kg
- Pregnant females
- Intubated patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Isadora Botwinick, MD, 631-444-8329, isadora.botwinick@stonybrookmedicine.edu
Charles Mikell, MD, 631-444-9137, charles.mikell@stonybrookmedicine.edu
About this study
Official title: Transauricular Vagus Nerve Stimulation (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 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.
Read more
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.
Read the detailed description
This will be a single-arm, open-label trial to assess the brain blood oxygen saturation and EEG of hospitalized patients with delirium, and to assess feasibility and safety of transauricular vagus nerve stimulation (taVNS) in this population. 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 to a barely perceptible threshold. 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. Prior to initiation of taVNS on the first day, subjects will undergo 10 minutes of neurophysiological monitoring to determine baseline recording. Cerebral oxygenation, hemodynamics, and EEG will be documented using the Masimo O3/Sedline brain monitoring system, a noninvasive, commercially available brain monitor. The Masimo O3/Sedline device will continue to be used to monitor the patient while undergoing taVNS to record further data for another 10 minutes during the first stimulation session.
Subjects will be prescribed two 30-minute sessions of taVNS stimulation each day with a minimum of 6 hours between sessions for a maximum of 7 days until either delirium resolves, or the patient is discharged.
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 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. Due to the nature of ICU care, compliance with the protocol will be defined as completing at least 1 stimulation session during the 7-day study period.
- Conditions
- Delirium Treatment, Delirium
- Being tested
- Transauricular Vagus Nerve Stimulation
- Keywords
- delirium, tavns, transauricular vagus nerve stimulation, vagus nerve stimulation, transcutaneous vagus nerve stimulation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TaVNS and Usual Care for Delirium | Experimental | 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, for a maximum of 7 days, until delirium resolves or the patient is discharged from the ICU. Receives: Device: Transauricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of taVNS in hospitalized patients with delirium
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:
- 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.
- At least 80% of patients achieve ≥10% of prescribed stimulation.
Measured: From enrollment to end of treatment at a maximum of 7 days
Feasibility of taVNS in delirious hospitalized patients
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:
- 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.
- At least 80% of patients achieve ≥10% of prescribed stimulation.
Measured: From enrollment to the end of study at a maximum of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start26 Sep 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Delirium TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isadora Botwinick, Stony Brook University
- Investigators
- Isadora Botwinick, MD, Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258082
- Sponsor's protocol ID
- IRB2025-00131
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD will be shared
Publications
Wilson JE, Mart MF, Cunningham C, Shehabi Y, Girard TD, MacLullich AMJ, Slooter AJC, Ely EW. Delirium. Nat Rev Dis Primers. 2020 Nov 12;6(1):90. doi: 10.1038/s41572-020-00223-4.
PubMed 33184265Huffman WJ, Subramaniyan S, Rodriguiz RM, Wetsel WC, Grill WM, Terrando N. Modulation of neuroinflammation and memory dysfunction using percutaneous vagus nerve stimulation in mice. Brain Stimul. 2019 Jan-Feb;12(1):19-29. doi: 10.1016/j.brs.2018.10.005. Epub 2018 Oct 9.
PubMed 30337243Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.
PubMed 29361441Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. doi: 10.1093/gerona/63.7.764.
PubMed 18693233
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transauricular Vagus Nerve Stimulation (taVNS) for Delirium
- ClinicalTrials.gov ID
- NCT07258082
- Acronym / sponsor ID
- IRB2025-00131
- Conditions
- Delirium Treatment, Delirium
- Keywords
- delirium, tavns, transauricular vagus nerve stimulation, vagus nerve stimulation, transcutaneous vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a single-arm, open-label trial to assess the brain blood oxygen saturation and EEG of hospitalized patients with delirium, and to assess feasibility and safety of transauricular vagus nerve stimulation (taVNS) in this population. 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 to a barely perceptible threshold. 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. Prior to initiation of taVNS on the first day, subjects will undergo 10 minutes of neurophysiological monitoring to determine baseline recording. Cerebral oxygenation, hemodynamics, and EEG will be documented using the Masimo O3/Sedline brain monitoring system, a noninvasive, commercially available brain monitor. The Masimo O3/Sedline device will continue to be used to monitor the patient while undergoing taVNS to record further data for another 10 minutes during the first stimulation session.
Subjects will be prescribed two 30-minute sessions of taVNS stimulation each day with a minimum of 6 hours between sessions for a maximum of 7 days until either delirium resolves, or the patient is discharged.
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 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. Due to the nature of ICU care, compliance with the protocol will be defined as completing at least 1 stimulation session during the 7-day study period.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TaVNS and Usual Care for Delirium | Experimental | Device: Transauricular Vagus Nerve StimulationHospitalized, 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, for a maximum of 7 days, until delirium resolves or the patient is discharged from the ICU. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stony Brook University Hospital inpatient, Age > 22
- Right- handed
- Screen positive for delirium on ICDSC instrument
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transauricular Vagus Nerve StimulationTaVNS 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. | Device | TaVNS and Usual Care for Delirium |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 33184265Wilson JE, Mart MF, Cunningham C, Shehabi Y, Girard TD, MacLullich AMJ, Slooter AJC, Ely EW. Delirium. Nat Rev Dis Primers. 2020 Nov 12;6(1):90. doi: 10.1038/s41572-020-00223-4.
- Background: PubMed 30337243Huffman WJ, Subramaniyan S, Rodriguiz RM, Wetsel WC, Grill WM, Terrando N. Modulation of neuroinflammation and memory dysfunction using percutaneous vagus nerve stimulation in mice. Brain Stimul. 2019 Jan-Feb;12(1):19-29. doi: 10.1016/j.brs.2018.10.005. Epub 2018 Oct 9.
- Background: PubMed 29361441Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.
- Background: PubMed 18693233Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. doi: 10.1093/gerona/63.7.764.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isadora Botwinick, MD principal investigator
Stony Brook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular Vagus Nerve Stimulation in people with Delirium Treatment and Delirium, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isadora Botwinick, MD (631-444-8329, isadora.botwinick@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of taVNS in hospitalized patients with delirium (time frame: From enrollment to end of treatment at a maximum of 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258082, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.