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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary arm | Experimental | All participants in the study we receive the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity focused ultrasound using the NeurGear Zenbud | Device | The NeurGear Zenbud is a wearable earbud that delivers low intensity focused ultrasound to the auricular branch of the vagus nerve |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeurGear | Rochester | New York | 14618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29844694 | Background | Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018 May 16;11:203-213. doi: 10.2147/JIR.S163248. eCollection 2018. |
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| 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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