NCT06574971

Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: NeurGear · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if low intensity fodused ultrasound stiulation delivered to the auricular branch of the vagus nerve works to mitigate symptoms of anxiety disorder in adults. It will also learn about the safety and feasibility of low intensity focused ultrasound stimulation. The main questions it aims to answer are: Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for reducing the symptoms of anxiety disorders? Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for improving quality of life and sleep for individuals who suffer from anxiety disorders? Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for reducing the symptoms of depression for individuals who suffer from anxiety disorders? Is the Neurgear Zenbud a safe, accessible, and feasible way of treatment for individuals who suffer from anxiety disorders? Participants will: Use the ZenBud device, a wearable low intensity focused ultrasound delivery device, for 5 minutes a day, every day for 4 weeks Complete a weekly Becks Anxiety Inventory, Becks, Depression Inventory, Pittsburgh Sleep Quality Index questionnaire, and PCL-5 weekly Complete a post study survey asking questions about subjective efficacy and quality of life improvements.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
DEVICE	Low intensity focused ultrasound using the NeurGear Zenbud	The NeurGear Zenbud is a wearable earbud that delivers low intensity focused ultrasound to the auricular branch of the vagus nerve

Timeline

• Start date: 2024-08-15
• Primary completion: 2024-10-15
• Completion: 2025-08-15
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States