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

NCT05717439 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 338

Last updated 2024-12-11

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

CAPS-5-R

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

DIAGNOSTIC_TEST

Senseye DT

Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.

Sponsors & Collaborators

  • Senseye, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-07-25
Completion
2024-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717439 on ClinicalTrials.gov