Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574971
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Pre-Post Intervention Study to Investigate the Safety Feasibility Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety Anxiety-Related Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None