TaVNS for Delirium
This study is testing a non-invasive device called transauricular vagus nerve stimulation (taVNS) for patients in the hospital who have delirium. Delirium is a state of confusion that can happen to people who are sick or hurt, making it hard to pay attention or understand things. The taVNS device uses a clip-on electrode on the left ear to deliver stimulation. Researchers want to see if taVNS is safe and practical for critically ill patients, if they and staff can tolerate the treatments, and if it changes brain activity or oxygen levels. This study aims to enroll 10 right-handed adults over 22 years old at Stony Brook University Hospital who screen positive for delirium. The main goal is to see if taVNS is feasible (can be done) and safe for these patients.
- Study design
- This is an early feasibility study with a single-arm, open-label design, meaning all 10 participants will receive the taVNS treatment. There is no comparison group or placebo.
- What's involved
- You would receive taVNS twice daily for about 30 minutes per session, at least 6 hours apart, for up to 7 days or until your delirium resolves. The treatment starts within 24 hours of agreeing to participate.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess feasibility and safety from enrollment until the end of treatment, which is a maximum of 7 days.
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TaVNS for Delirium
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Isadora Botwinick, MD · PRINCIPAL_INVESTIGATOR · Stony Brook University Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility of taVNS in hospitalized patients with deliriumFrom 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 patientsFrom 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.