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Effect of (TaVNS) on Anxiety and Brain Function in Distressed Health Care Workers
NCT05132881 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this research is to measure alterations in anxiety and brain activity associated with the use of an approved health device called Transauricular Vagal Nerve Stimulation (TaVNS) in distressed persons who work in a health care and distressed healthcare workers in the the Philadelphia, PA region. The Investigators will be using functional magnetic resonance imaging (or fMRI) to measure changes in each subject's brain function during the use of VNS. This study is designed to allow researchers to understand the changes in cerebral (brain) activity that occur when a subject uses VNS. Thus, the primary goal of the proposed study is to evaluate the ability of the TaVNS system to reduce distress and change neurophysiology among health care providers. The Investigators, hypothesize that using the TaVNS device will help reduce distress in individuals. In order to understand the mechanisms of change that occur while using the VNS study, the Investigators have added a substudy of participants who do not experience high levels of distress to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device. In addition to the primary aims of the overalll study to assess distress in workers while enrolled in a TaVNS program, a subgroup of 50 subjects will undergo functional magnetic resonance imaging (fMRI) while using the VNS device to assess the changes in the brain including neurophysiological effects of TaVNS. The goal of this substudy is to observe the changes in the brain while using the TaVNS earbuds in the MRI to increase our understanding of the mechanisms and processing involved while using TaVNS. In this substudy, which is amendment version 3.0, the investigators have increased the number of persons to include 50 subjects who will use the device in the MRI to evaluate the neural processes and cerebral blood flow while using TaVNS.
Conditions Studied
Interventions
- OTHER Waitlist Control
- OTHER Neuvana 2.0 Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS)
- OTHER Healthy Controls: Substudy Group III
- OTHER Distressed Workers: Subgroup II
Study Locations (1)
Pennsylvania
- Thomas Jefferson University, Marcus Institute of Integrative Health Centers — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2025-11-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05132881
The ClinicalTrials.gov registry entry for NCT05132881 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 324 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Healthy appearing as the primary indexed condition, and to 4 interventions — of which Waitlist Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05132881 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05132881 about?
NCT05132881 is a clinical study titled "Effect of (TaVNS) on Anxiety and Brain Function in Distressed Health Care Workers". The purpose of this research is to measure alterations in anxiety and brain activity associated with the use of an approved health device called Transauricular Vagal Nerve Stimulation (TaVNS) in distressed persons who work in a health care and distressed healthcare workers in the the Philadelphia, P...
What is the current status of trial NCT05132881?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2021-04-01. Estimated completion is 2025-11-20.
What conditions does trial NCT05132881 study?
This clinical trial studies the following conditions: Healthy, Anxiety, Distress, Emotional, Effects of Vibration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05132881?
The interventions under investigation include: Waitlist Control (OTHER), Neuvana 2.0 Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS) (OTHER), Healthy Controls: Substudy Group III (OTHER), Distressed Workers: Subgroup II (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05132881?
This trial is sponsored by Thomas Jefferson University, which has 324 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05132881 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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