NCT07218263

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

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
2 months until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

October 13, 2025

Last Update Submit

August 17, 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)

Assessment Group

EXPERIMENTAL

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

Diagnostic Test: AI-enabled Okaya platform

Interventions

AI-enabled Okaya platformDIAGNOSTIC_TEST

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

Assessment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • English is not primary language or requires a translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Health - Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health - University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

FatigueDepression

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
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 22, 2025

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)