NCT07218263

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

October 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 25, 2026

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

October 13, 2025

Last Update Submit

February 23, 2026

Conditions

Depression DisordersFatigue SymptomCardiovascular

Keywords

FatigueDepressionArtificial Intelligence

Outcome Measures

Primary Outcomes (3)

  • Correlation between Okaya (AI based) score and PHQ-9

    Regression analysis comparing Okaya scores to PHQ-9

    Baseline

  • Correlation between Okaya (AI) based score and PHQ-9 and FAS

    Regression analysis comparing Okaya scores to standard assessments

    Baseline

  • Correlation between Okaya (AI based) score and FAS

    Regression analysis comparing Okaya scores to FAS

    Baseline

Secondary Outcomes (1)

  • Usability and patient satisfaction

    Baseline

Study Arms (1)

Single Group Assignment

Participants will complete PHQ-9, FAS, and Okaya assessments.

Diagnostic Test: Participants will complete PHQ-9, FAS, and Okaya assessments.

Interventions

Participants will complete PHQ-9, FAS, and Okaya assessments.DIAGNOSTIC_TEST

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

Single Group Assignment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants will be selected from both inpatient and outpatient setting.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46074, United States

NOT YET RECRUITING

Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

FatigueDepression

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

Brijesh Patel, DO

CONTACT

317-963-8637patebr@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine

Study Record Dates

First Submitted

October 13, 2025

First Posted

October 20, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 25, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)