Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
NCT Number: NCT06574971
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety Disorders
Sponsor: NeurGear
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-08-15

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.

Primary Outcome Measures: Becks Anxiety Inventory, The Beck Anxiety Inventory (BAI) is a 21-question self-report inventory that measures anxiety levels in adults and adolescents. It was written by Aaron T. Beck, M.D., and R.A. Steer. The BAI is used to assess the intensity of physical and cognitive anxiety symptoms during the past week., From enrollment to the end of treatment at 4 weeks
Secondary Outcome Measures: Pittsburg Sleep Quality Index, The Pittsburgh Sleep Quality Index (PSQI) is a 19-question questionnaire that assesses sleep quality and disturbances over a one-month period. It's designed for clinical populations and is valid and has acceptable psychometric properties when used in men and non-pregnant women in diverse global settings., From enrollment to the end of treatment at 4 weeks|Becks Depression Inventory, The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire that assesses the level of depression in adults. The BDI measures both cognitive and physical symptoms of depression, such as sadness, pessimism, and worthlessness. It generates a single score that indicates the severity of depression as minimal, mild, moderate, or severe. The individual scale items are scored on a 4-point continuum, with a total summed score range of 0-63. Higher scores indicate greater depressive severity., From enrollment to the end of treatment at 4 weeks|PTSD Checklist for DSM-5, The Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) is a 20-item self-report tool that assesses the 20 symptoms of PTSD in adults. It's designed for people who have experienced traumatic events. The PCL-5 can help with: Monitoring symptom changes during and after treatment, Screening people for PTSD, and Making provisional PTSD diagnoses, From enrollment to the end of treatment at 4 weeks