Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD

NCT05717439 | Completed FDA Device

• 1 other identifier: CSP-PT-0003
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

PTSD; Generalized Anxiety Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Time to Administer Tool

  Baseline & 12 weeks

Study Arms (6)

PTSD positive

Subjects meet criteria for PTSD, with or without comorbid Generalized Anxiety Disorder or Major Depressive Disorder

Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT

Primary GAD

Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder

Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT

Primary MDD

Subjects DO NOT meet criteria for PTSD, but meet criteria for Major Depressive Disorder

Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT

Comorbid GAD/MDD

Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder and Major Depressive Disorder

Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT

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

Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT

Trauma-negative

Subjects DO NOT have trauma exposure meeting DSM-5-TR Criterion A and DO NOT meet criteria for PTSD, GAD, or MDD

Diagnostic Test: Senseye DT

Interventions

CAPS-5-R DIAGNOSTIC_TEST

A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.

Also known as: Clinician-Administered Scale for PTSD for DSM-5, Revised version

Comorbid GAD/MDD; PTSD positive; Primary GAD; Primary MDD; Trauma-positive, PTSD/GAD/MDD-negative

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.

Comorbid GAD/MDD; PTSD positive; Primary GAD; Primary MDD; Trauma-negative; Trauma-positive, PTSD/GAD/MDD-negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with or without PTSD, Generalized Anxiety Disorder (GAD), and/or Major Depressive Disorder (MDD)

You may qualify if:

• Willing and able to read, understand, and sign the IRB-approved Informed Consent Form.
• Age 18+.
• Study groups: Diagnosed with PTSD, GAD, and/or MDD.
• Control groups: Not diagnosed with PTSD, GAD, or MDD.
• Deemed likely to comply with the study protocol, including willing communication of adverse events (AEs), mental health treatment history, current and past psychiatric medication, and ability to attend all study follow-up visits.
• Medically stable as determined by the clinician or investigator.
• Virtual sites: Subject has access to a stable internet and WIFI connection and an iPhone 11 or newer.

You may not qualify if:

• Psychotic or self-injurious behavior.
• Current diagnosis of epilepsy and/or other current seizure disorders.
• A history of or positive at screening for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, and psychosis.
• Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions).
• Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
• Current eye disorders which prevent the patient from using the Senseye DT (complete list in full protocol).
• Active suicidal and/or homicidal intent which may put the participant and/or others at risk per the investigator's clinical judgement, or has suicidal ideation with intent to act within 6 months prior to the start of the screening phase as determined by a C-SSRS score \> 3, or history of suicidal behavior within the past year prior to the start of the screening phase.
• Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of psychotropic and/or non-psychotropic drugs/medication which may affect use of the Senseye DT (complete list in full protocol).
• Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or electroconvulsive therapy.
• Any condition which precludes the ability for subjects to safely and accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT (e.g., significant developmental disabilities, language disorders, cognitive deficiencies, or other neurodevelopmental disorders).
• Traumatic Brain Injury (TBI) within the last 12 months.
• Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS.
• Pregnant or intending on becoming pregnant during the duration of the study as determined by self-report.
• Currently incarcerated.
• Participant requires a legal guardian to consent.

Sponsors & Collaborators

• Senseye, Inc.: lead

Study Sites (5)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, 29401, United States

Location

Future Search Trials

Dallas, Texas, 75231, United States

Location

DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders; Depressive Disorder; Mood Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: March 1, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)