Senseye Diagnostic Tool for Post-Traumatic Stress Disorder

Not yet recruiting at 3 trial locations

Overseen By Priscilla Nechrebecki

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Senseye, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD.

The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a a Machine Learning (ML) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the ML algorithm, then test it for accuracy.

The main questions this study aims to answer are:

1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing?

2. How accurately does the Senseye DT predict PTSD severity?

3. How fast is the Senseye DT to use compared to structured clinical interviews?

Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits:

* Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected.

* Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually.

* Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually.

The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

Are You a Good Fit for This Trial?

Adults 18+ with symptoms of PTSD, who can attend virtual visits and possibly an in-person session if near a study site. Exclusion criteria are not specified but typically would include factors that could interfere with the diagnostic tool's assessment or individuals' ability to participate fully.

Inclusion Criteria

Deemed likely to comply with the study protocol by the study team, including willing communication of adverse events (AEs), mental health history, current and past psychiatric medication & treatments, and ability to attend all study visits

I am 18 years old or older.

The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF)

Exclusion Criteria

I have epilepsy or another seizure disorder.

A history of at Screening OR positive at Visit 1 for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, compromised facial neuro-ophthalmic integrity, 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, active suicidal and/or homicidal intent or other self-injurious behavior, suicidal behavior within the last year, significant suicidal ideation within the last 6 months, current reported usage of specific drugs and medications, current reported usage of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or other stimulation or energy-based therapies, any condition which precludes the ability for patients to safely and accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT, medical diagnosis of Traumatic Brain Injury (TBI) within the last 12 months, lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder, involvement in active litigation related to the participant's psychiatric symptoms, pregnancy, current incarceration, participant requiring a legal authorized representative to consent, prior enrollment in this study or in other Senseye Machine Learning (ML) studies within the last 12 months, unwilling or unable to comply with all study related procedures in the opinion of the investigator

What Are the Treatments Tested in This Trial?

Interventions

• Senseye Diagnostic Tool

Trial Overview The REVEAL study is testing the Senseye Diagnostic Tool, an iPhone app using machine learning to diagnose PTSD by analyzing videos recorded during tasks. It compares this tool's accuracy and speed against structured clinical interviews like SIGMA, SIGH-A, MINI Interview, and CAPS-5-R.

How Is the Trial Designed?

Group I: PTSD assessment comparing the Senseye DT to the clinical reference standard Experimental Treatment 2 Interventions

All participants enrolled will be administered both the Senseye DT and the CAPS-5-R. The CAPS-5-R is used as the study's clinical reference standard to establish the "ground truth" for PTSD presence and severity. The order of administration will be randomized.

Who Is Running the Clinical Trial?

Senseye, Inc.

Lead Sponsor

Trials

2

Recruited

400+

Lindus Health

Industry Sponsor

Trials

12

Recruited

17,000+