Study Stopped
No participants completed study
Senseye's OBCI Diagnostic Tool for PTSD
Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
1 other identifier
observational
61
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2022
CompletedFirst Submitted
Initial submission to the registry
April 27, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2023
CompletedApril 12, 2023
April 1, 2023
9 months
April 27, 2022
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Agreement between Senseye OBCI measures and gold-standard measures
Assessments for the presence and severity of PTSD symptoms will be compared between the Senseye tool and the gold-standard measures for percent agreement.
9 weeks
Feasibility of the Senseye tool
Feasibility will be assessed by evaluating retention rate.
9 weeks
Test-retest for repeatability of the Senseye tool
Senseye OBCI assessments will be repeated the same day and again at one week.
1 week
Secondary Outcomes (1)
Prognostic value by comparing Senseye OBCI to core PTSD symptoms
9 weeks
Study Arms (3)
Trauma+ & PTSD
Patients diagnosed with significant trauma exposure and PTSD
Trauma+ & No PTSD
Patients diagnosed with significant trauma exposure but no PTSD
No trauma or PTSD
Healthy adults without known major psychiatric disorders
Interventions
A validated, semi-structured clinical interview to assess core PTSD symptoms
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.
Eligibility Criteria
Adults presenting to the clinic with potential psychiatric disorder, to include PTSD
You may qualify if:
- Male/Female diagnosed with PTSD (only for PTSD group)
- aged 18- 65 years old
- able to read/write in English
You may not qualify if:
- presence of intellectual disabilities
- psychotic or self-injurious behavior
- seizure disorder
- major depression
- traumatic brain injury (TBI)
- language disorder
- eye disorders
- other neurodevelopmental disorders
- history of lifetime psychosis
- mania
- current suicidality
- diagnosis of a substance use disorder
- impaired functioning to the degree that requires immediate initiation of psychotropic medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Senseye, Inc.lead
Study Sites (1)
Olive View - UCLA Medical Center
Sylmar, California, 91342, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naser Ahmadi, MD
Olive View - UCLA
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2022
First Posted
May 12, 2022
Study Start
April 25, 2022
Primary Completion
January 11, 2023
Study Completion
January 11, 2023
Last Updated
April 12, 2023
Record last verified: 2023-04