Anxiety Disorders
Conditions
Keywords
Anxiety disorders, low intensity focused ultrasound, auricular nerve, vagus nerve
Brief 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.
Interventions
DEVICELow 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
NeurGear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scoring ≥ 28 on the Beck's Anxiety Inventory 2. Age 18 or older. 3. Ability to independently provide informed consent. 4. Ability to comply with the daily treatment and weekly assessments 5. Ability to communicate in English.
Exclusion criteria
1. Scoring below the aforementioned cutoff on the BAI 2. Inability to comply with the treatment and assessment protocol 3. Age less than 18 years. 4. Inability to provide informed consent. 5. Conditions for which ultrasound is contraindicated including cancer, pacemaker, and impaired sensory sensitivity. 6. Conditions for which vagus nerve stimulation is contraindicated including history of vagotomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Becks Anxiety Inventory | From enrollment to the end of treatment at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburg Sleep Quality Index | From enrollment to the end of treatment at 4 weeks | 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. |
| Becks Depression Inventory | From enrollment to the end of treatment at 4 weeks | 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. |
| PTSD Checklist for DSM-5 | From enrollment to the end of treatment at 4 weeks | 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 |
Countries
United States
Outcome results
None listed