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NCT04935697 · ClinicalTrials.gov registry record · NA
Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress
A NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04935697 is a NA study that has completed, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 3 participants.
The verdict
NCT04935697, a NA study, has completed, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients with mild-to-moderate traumatic brain injury (TBI) to prevent the progression towards immunokine storms, systemic inflammatory response syndrome (SIRS), severe respiratory distress, and requirement for invasive mechanical ventilation, and death, when compared to SOC alone (the control arm).
Interventions
- OTHER SOC
- DEVICE nVNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-08-04 |
| Est. Completion | 2025-03-01 |
| Phase | NA |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04935697
The ClinicalTrials.gov registry entry for NCT04935697 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SOC is the first listed.
NCT04935697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04935697 about?
NCT04935697 is a clinical study titled "Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress". This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients with mild-to-moderate traumatic brain injury (TBI) to prevent the progre...
What is the current status of trial NCT04935697?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2021-08-04. Estimated completion is 2025-03-01.
What interventions are being tested in trial NCT04935697?
The interventions under investigation include: SOC (OTHER), nVNS (DEVICE).
Who is sponsoring clinical trial NCT04935697?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
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