Senseye's OBCI Diagnostic Tool for PTSD
NCT05372523 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 61
Last updated 2023-04-12
Summary
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the Senseye OBCI diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. A total of 68 adults will be included in the study with a follow-up time point of 9 weeks post-initial intervention.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
CAPS-5 Assessment
A validated, semi-structured clinical interview to assess core PTSD symptoms
- DIAGNOSTIC_TEST
-
Senseye OBCI
Using a machine learning algorithm, Senseye's DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Sponsors & Collaborators
-
Senseye, Inc.
lead INDUSTRY
Principal Investigators
-
Naser Ahmadi, MD · Olive View - UCLA
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-25
- Primary Completion
- 2023-01-11
- Completion
- 2023-01-11
- FDA Device
- Yes
Countries
- United States
Study Locations
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