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Recruiting NCT07218263

AI Platform for Fatigue and Depression Detection

Observational Depression Disorders Fatigue Symptom Cardiovascular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Participants will complete PHQ-9, FAS, and Okaya assessments..
Who it may be relevant to
Registry conditions: Depression Disorders, Fatigue Symptom, Cardiovascular. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of a Novel Web-based Fatigue and Cognitive Assessment Platform in Detecting Fatigue and Depression

Overview

This observational study evaluates the accuracy of the Okaya AI platform in detecting fatigue and depression in cardiology patients, comparing its assessments to PHQ-9 and Fatigue Assessment Scale scores.

Detailed description

Patients frequently experience fatigue and depression, which are often underdiagnosed due to limitations in traditional screening tools. This study introduces the Okaya platform, a browser-based AI system that analyzes facial and vocal biomarkers collected during conversational check-ins. The platform uses computer vision and natural language processing to extract features such as eye contact, facial affect, pitch, volume, and speech patterns. These features are processed through regression models to generate a composite AI based score. The study aims to validate this score against PHQ-9 and FAS assessments. Participants will complete a single baseline check-in using the Okaya platform and complete standard questionnaires. No interventions will be provided.

Interventions

  • Diagnostic test Participants will complete PHQ-9, FAS, and Okaya assessments.
    AI-based conversational assessment using facial and vocal features to evaluate fatigue and depression.

Primary outcome measures

  • Correlation between Okaya (AI based) score and PHQ-9 [Time frame: Baseline]
  • Correlation between Okaya (AI) based score and PHQ-9 and FAS [Time frame: Baseline]
  • Correlation between Okaya (AI based) score and FAS [Time frame: Baseline]
Secondary outcome measures (1)
  • Usability and patient satisfaction [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Age ≥18, English-speaking, able to consent

Exclusion criteria

  • Active substance use, nonverbal, cognitive disability, active suicidal/homicidal ideation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Indiana University — Indianapolis
  • Methodist Hospital — Indianapolis

Identifiers

NCT: NCT07218263 · IU-Okaya-2025 · IRB #25854

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗