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The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.
This clinical study will be conducted to inform and train the Senseye DT's machine learning algorithm, to be evaluated in a future study for effectiveness in identifying people with PTSD compared to the Clinician-Administered PTSD Scale for DSM-5, revised version (CAPS-5-R) assessment. The Senseye DT is designed to utilize video data captured from a subject's eyes while they are presented various visual stimuli to extract ocular metrics (i.e., pupil size, gaze pattern, etc.) and heart rate data and use this information to detect the presence and severity of PTSD. Due to the overlapping symptomatology between PTSD, GAD, and MDD and common elements of ANS abnormalities (e.g., hyperarousal in both PTSD and GAD), it is necessary for the Senseye DT's specificity to discern between PTSD, GAD and MDD. This study is therefore designed to fully assess the presence and severity of each of these disorders in subjects to ensure device specificity as well as to test the feasibility to diagnose and rate severity of these conditions.
The study will be divided into two concurrent phases:
Phase I will focus on assessing the presence of PTSD via Screening through Baseline Study Visits. The objective of this phase is to obtain an accurate baseline diagnosis and severity rating for PTSD using Standard of Care methods and to use the Senseye DT to obtain data necessary for the device to be trained to produce a PTSD diagnosis. Baseline diagnosis and severity of GAD and MDD will also be determined.
Phase II will focus on assessing the severity of PTSD symptoms over time, with the objective to collect data necessary to train the Senseye DT machine learning algorithm to accurately determine a subject's PTSD severity rating correlated to the CAPS-5-R. Phase II consists of follow-up time points of 4 weeks, 8 weeks, and 12 weeks, and assesses changes in PTSD since the baseline severity determined in Phase I. Changes in GAD and MDD from baseline will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD positive | Subjects meet criteria for PTSD, with or without comorbid Generalized Anxiety Disorder or Major Depressive Disorder |
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| Primary GAD | Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder |
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| Primary MDD | Subjects DO NOT meet criteria for PTSD, but meet criteria for Major Depressive Disorder |
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| Comorbid GAD/MDD | Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder and Major Depressive Disorder |
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| Trauma-positive, PTSD/GAD/MDD-negative | Subjects have trauma exposure meeting DSM-5-TR Criterion A, but DO NOT meet criteria for PTSD, GAD, or MDD |
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| Trauma-negative |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPS-5-R | Diagnostic Test | A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating. |
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| Measure | Description | Time Frame |
|---|---|---|
| Agreement between Senseye DT and CAPS-5-R assessment at baseline | The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at Baseline. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test. | Baseline |
| Agreement between Senseye DT and CAPS-5-R at 12 weeks | The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at the 12-week follow-up time point. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test. | 12 weeks |
| Establishment of Ground Truth - PTSD | To obtain data using the Senseye DT measures in both PTSD and control subjects to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of PTSD. | Baseline & 12 weeks |
| Establishment of Ground Truth - GAD/MDD | To obtain data using the Senseye DT to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of GAD and/or MDD. | Baseline & 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Administer Tool | The Senseye DT demonstrates significantly less time to administer than the CAPS-5-R, based on actual recorded time for study staff to administer each assessment. Senseye DT time and CAPS-5-R time will be compared using a 2-sample t-test or Wilcoxon rank-sum test. | Baseline & 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with or without PTSD, Generalized Anxiety Disorder (GAD), and/or Major Depressive Disorder (MDD)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Velocity Clinical Research |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000098647 | Generalized Anxiety Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
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Subjects DO NOT have trauma exposure meeting DSM-5-TR Criterion A and DO NOT meet criteria for PTSD, GAD, or MDD |
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| Senseye DT | Diagnostic Test | Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout. |
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| Meridian |
| Idaho |
| 83642 |
| United States |
| Ralph H. Johnson VA Health Care System | Charleston | South Carolina | 29401 | United States |
| Future Search Trials | Dallas | Texas | 75231 | United States |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | United States |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |