Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Subjective Units of Distress Survey |
The Subjective Units of Distress Survey (SUDS) is a way for participants to communicate how much distress they are currently feeling using a 0 to 10 scale with zero corresponding to a relaxed state without distress and ten corresponding to extreme distress filled with panic, tension, fear, and anxiety. |
Screening Measure Subjects will be evaluated at baseline. |
|
Primary |
Subjective Units of Distress Survey |
The Subjective Units of Distress Survey (SUDS) is a way for participants to communicate how much distress they are currently feeling using a 0 to 10 scale with zero corresponding to a relaxed state without distress and ten corresponding to extreme distress filled with panic, tension, fear, and anxiety. |
Change from baseline and after using the TaVNS system approximately 90 days (~3 months)] . |
|
Primary |
Subjective Units of Distress Survey |
The Subjective Units of Distress Survey (SUDS) is a way for participants to communicate how much distress they are currently feeling using a 0 to 10 scale with zero corresponding to a relaxed state without distress and ten corresponding to extreme distress filled with panic, tension, fear, and anxiety. |
Evaluate at baseline to evaluate distress for healthy controls in Group III |
|
Primary |
Heart Rate Variability for Active and Waitlist |
Heart rate variability (HRV) is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. |
Screening Measure Subjects will be evaluated at baseline |
|
Primary |
Heart Rate Variability for Active and Waitlist |
Heart rate variability (HRV) is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. |
Change from baseline and after using the TaVNS system approximately 90 days (~3 months)] . |
|
Primary |
Galvanic Skin Resistance (GSR) for Active and Waitlist |
To measure changes in sweat gland activity, which reflect the intensity of participants' emotional state |
Screening Measure Subjects will be evaluated at baseline |
|
Primary |
Galvanic Skin Resistance (GSR) for Active and Waitlist |
To measure changes in sweat gland activity, which reflect the intensity of participants' emotional state |
Change from baseline and after using the TaVNS System approximately 90 days (~3 months)] |
|
Primary |
Functional magnetic resonance imaging (fMRI) in all groups |
This scan will be used to assess functional connectivity, tractography, and brain volume |
Subjects will be evaluated at baseline |
|
Primary |
Functional magnetic resonance imaging (fMRI) in Active and Waitlist Groups |
This scan will be used to assess functional connectivity, tractography, and brain volume |
Change from baseline and after using the TaVNS system approximately 90 days (~3 months)] . |
|
Primary |
Blood Oxygen Level Dependent Imaging scan in all groups |
Blood Oxygen Level Dependent Imaging (BOLD) scan analysis, used to observe different areas of the brain or other organs, which are found to be active at any given time. |
Subject will be evaluated at baseline |
|
Primary |
Blood Oxygen Level Dependent Imaging scan in Active and Waitlist Groups |
Blood Oxygen Level Dependent Imaging (BOLD) scan fMRI analysis, used to observe different areas of the brain or other organs, which are found to be active at any given time. |
Change from baseline and after using the TaVNS System approximately 90 days (~3 months)] |
|
Primary |
Arterial spin labeling scan in all groups |
Arterial spin labeling (ASL) scan fMRI analysis, used to quantify cerebral blood perfusion by labelling blood water as it flows throughout the brain. |
Subjects will be evaluated at baseline |
|
Primary |
Arterial spin labeling scan in Active and Waitlist Groups |
Arterial spin labeling (ASL) scan fMRI analysis used to quantify cerebral blood perfusion by labelling blood water as it flows throughout the brain. |
Change from baseline and after using the TaVNS System approximately 90 days (~3 months)] |
|
Secondary |
The Maslach Burnout Scale |
To measure feelings of being emotionally overextended and exhausted for health care professionals.The higher the score in each subgroup, the higher the emotional exhaustion and depersonalization, or the lower the sense of personal accomplishment. |
Subjects will be evaluated at baseline with questionnaires. |
|
Secondary |
The Maslach Burnout Scale |
To measure feelings of being emotionally overextended and exhausted for health care professionals.The higher the score in each subgroup, the higher the emotional exhaustion and depersonalization, or the lower the sense of personal accomplishment. |
Subjects will be evaluated at approximately three months follow up with questionnaires. |
|
Secondary |
The Maslach Burnout Scale |
To measure feelings of being emotionally overextended and exhausted for health care professionals. The higher the score in each subgroup, the higher the emotional exhaustion and depersonalization, or the lower the sense of personal accomplishment. |
Subjects will be evaluated approximately six months follow up with questionnaires. |
|
Secondary |
Patient Health Questionnaire |
Patient Health Questionnaire (PHQ-9)(depression) is the depression module to monitor the severity of depression and response to treatment. The range of the possible scores for the PHQ-9 are 0-27 with higher scores for worse symptoms. |
Subjects will be evaluated at baseline with questionnaires. |
|
Secondary |
Patient Health Questionnaire |
Patient Health Questionnaire (PHQ-9)(depression) is the depression module to monitor the severity of depression and response to treatment. The range of the possible scores for the PHQ-9 are 0-27 wither higher scores for worse symptoms. |
Subjects will be evaluated at approximately three months follow up with questionnaires. |
|
Secondary |
Patient Health Questionnaire (PHQ-9)(depression) |
Patient Health Questionnaire (PHQ-9)(depression) is the depression module to monitor the severity of depression and response to treatment.The range of the possible scores for the PHQ-9 are 0-27 with higher scores for worse symptoms. |
Subjects will be evaluated at baseline and approximately six months follow up with questionnaires. |
|
Secondary |
General Anxiety Disorder |
The General Anxiety Disorder (GAD-7) is a valid tool for screening for General Anxiety Disorder and assessing its severity. The GAD-7 consists of 7 questions that correspond to scores of anxiety. The range of scores is from 0 to 21; a higher score indicates greater anxiety. |
Subjects will be evaluated at baseline with questionnaires. |
|
Secondary |
General Anxiety Disorder |
The General Anxiety Disorder (GAD-7) is a valid tool for screening for General Anxiety Disorder and assessing its severity. The GAD-7 consists of 7 questions that correspond to scores of anxiety. The range of scores is from 0 to 21; a higher score indicates greater anxiety. |
Subjects will be evaluated at baseline and approximately three months follow up with questionnaires. |
|
Secondary |
General Anxiety Disorder |
The General Anxiety Disorder (GAD-7) is a valid tool for screening for General Anxiety Disorder and assessing its severity. The GAD-7 consists of 7 questions that correspond to scores of anxiety. The range of scores is from 0 to 21; a higher score indicates greater anxiety. |
Subjects will be evaluated at baseline and approximately six months follow up with questionnaires. |
|
Secondary |
Connor Davidson Resilience Scale-25 (CD-RISC) |
The Conner Davidson Resilience Scale-25 (CD-RISC-25) consists of 25 questions. The range of possible scores is 0-100 with a higher score indicating a higher chance of resiliency. The Connor-Davidson Resilience Scale is a test that measures resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma. |
Subjects will be evaluated at baseline with questionnaires. |
|
Secondary |
Connor Davidson Resilience Scale-25 |
The Conner Davidson Resilience Scale-25 (CD-RISC-25) consists of 25 questions. The range of possible scores is 0-100 with a higher score indicating a higher chance of resiliency. The Connor-Davidson Resilience Scale is a test that measures resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma. |
Subjects will be evaluated at approximately three months follow up with questionnaires. |
|
Secondary |
Connor Davidson Resilience Scale-25 |
The Conner Davidson Resilience Scale-25 (CD-RISC-25) consists of 25 questions. The range of possible scores is 0-100 with a higher score indicating a higher chance of resiliency. The Connor-Davidson Resilience Scale is a test that measures resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma. |
Subjects will be evaluated at baseline and approximately six months follow up with questionnaires. |
|
Secondary |
Insomnia Severity Index |
The Insomnia Severity Index (ISI) is a brief instrument comprised of 7 questions designed to assess the severity of both nighttime and daytime components of insomnia. The scores are rated 0-28 with higher scores corresponding to more sleep difficulties. |
Subjects will be evaluated at baseline with questionnaires. |
|
Secondary |
Insomnia Severity Index |
The Insomnia Severity Index (ISI) is a brief instrument comprised of 7 questions designed to assess the severity of both nighttime and daytime components of insomnia. The scores are rated 0-28 with higher scores corresponding to more sleep difficulties. |
Subjects will be evaluated at baseline and approximately three months follow up with questionnaires. |
|
Secondary |
Insomnia Severity Index |
The Insomnia Severity Index (ISI) is a brief instrument comprised of 7 questions designed to assess the severity of both nighttime and daytime components of insomnia. The scores are rated 0-28 with higher scores corresponding to more sleep difficulties. |
Subjects will be evaluated at baseline and approximately six months follow up with questionnaires. |
|
Secondary |
Global Severity Index of the Brief Symptom Inventory-18 |
The Brief Symptom Inventory (BSI-18) is a brief self-report survey to assess the extent of distress or annoyance. Responses were rated ranging from 1 to 5 for a total score of 18-90. A higher score indicates greater distress or annoyance. |
Subjects will be evaluated at baseline . |
|
Secondary |
Global Severity Index of the Brief Symptom Inventory-18 |
The Brief Symptom Inventory (BSI-18) is a brief self-report survey to assess the extent of distress or annoyance. Responses were rated ranging from 1 to 5 for a total score of 18-90. A higher score indicates greater distress or annoyance. |
Subjects will be evaluated at three months after using the TaVNS system. |
|
Secondary |
Global Severity Index of the Brief Symptom Inventory-18 |
The Brief Symptom Inventory (BSI-18) is a brief self-report survey to assess the extent of distress or annoyance. Responses were rated ranging from 1 to 5 for a total score of 18-90. A higher score indicates greater distress or annoyance. |
Subjects will be evaluated at six months after using the TaVNS system. |
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