MedTrace Logo

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

NCT06574971 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • NeurGear

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2024-10-15
Completion
2025-08-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574971 on ClinicalTrials.gov