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NCT05717439
Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults With PTSD
Conditions: PTSD
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: 1
Enrollment: 350
Sponsor: Senseye, Inc.
Summary
This pilot study will investigate the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of posttraumatic stress disorder (PTSD) symptoms and establish a "ground truth" for PTSD diagnosis and severity rating for the Senseye DT machine learning algorithm.
A total of 350 adults will be included in the study with a follow-up time point of 12 weeks post-initial intervention.
Eligibility Criteria
Inclusion Criteria:Willing and able to read, understand, and sign the IRB-approved ICF.Between the ages of 18 and 99.PTSD population: Participant is diagnosed with PTSDNon-PTSD population:Participant is not diagnosed with PTSD or other DSM-5 psychiatric conditions, and without trauma exposure; or,Participant is not diagnosed with PTSD but presents with positive traumatic exposure.Able to read/write in English.Participant is medically stable as determined by the clinician or investigator.Exclusion Criteria:Psychotic or self-injurious behavior.Epilepsy or other seizure disorders.Mania.Primary diagnosis of bipolar, schizophrenia, autism, Parkinson's, or obsessive- compulsive disorders.Compromised facial neuro-ophthalmic integrityEye disorders which prevent the patient from using the Senseye DT:Vision impairment preventing ability to read with correctionDisorders requiring use of eye drops, except artificial tears.Significant eye lid droop blocking the pupil.Persistent blurry vision, headaches, and/or light sensitivity resulting from conditions including abnormal pupil dilation or reactivityRecent eye surgeries (within 2 weeks) or planned eye surgeries within the study duration.Intraocular inflammation, including iritis and anterior uveitis.Ocular trauma resulting in uncorrected or permanent bilateral damage.Active suicidal and/or homicidal intent which may put the participant and/or others at risk as determined by the clinician or investigator.Current reported usage of psychotropic drugs and medication which may affect use of the Senseye DT:Narcotics/opioidsTricyclic antidepressantsMAOIsSelect antihypertensive medicationsStimulants except caffeine or nicotinePsychedelics/psychotomimeticsCholinergic or anticholinergic agentsSpravato or Ketamine.Any condition which precludes the ability for patients to complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DTRecent Traumatic Brain Injury (TBI) with vision changes lasting more than 24 hours.Pregnant or intending on becoming pregnant during the duration of the study.Currently incarcerated.Participant requires a legal guardian to consent.
Source: ClinicalTrials.gov (NCT05717439). StuddyBuddy aggregates publicly available trial information.