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AI Platform for Fatigue and Depression Detection

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07218263
Enrollment
100
Registered
2025-10-20
Start date
2025-12-22
Completion date
2026-05-31
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular, Depression Disorders, Fatigue Symptom

Keywords

Fatigue, Depression, Artificial Intelligence

Brief summary

This 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 clinical interventions will be provided.

Interventions

DIAGNOSTIC_TESTAI-enabled Okaya platform

AI-based conversational assessment using facial and vocal features to evaluate fatigue and depression.

Sponsors

Brijesh Patel
Lead SponsorOTHER
SmartTec Inc
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients referred to the cardiology clinic with acute or chronic issues, or hospitalized for acute cardiology issues will be enrolled. Inclusion Criteria: * Age ≥18, English-speaking, able to consent

Exclusion criteria

* Active substance use, nonverbal, cognitive disability, active suicidal/homicidal ideation * English is not primary language or requires a translator

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Okaya (AI based) score and FASBaselineRegression analysis comparing Okaya scores to FAS
Correlation between Okaya (AI) based score and PHQ-9 and FASBaselineRegression analysis comparing Okaya scores to standard assessments
Correlation between Okaya (AI based) score and PHQ-9BaselineRegression analysis comparing Okaya scores to PHQ-9

Secondary

MeasureTime frameDescription
Usability and patient satisfactionBaselineEase-of-use ratings on the Okaya platform

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026