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临床试验/NCT07218263
NCT07218263已完成不适用

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

Brijesh Patel4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
4
主要终点
Correlation between Okaya (AI based) score and PHQ-9

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Assessment Group

Experimental

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

干预措施: AI-enabled Okaya platform (Diagnostic Test)

结局指标

主要结局

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

时间窗: Baseline

Regression analysis comparing Okaya scores to PHQ-9

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

时间窗: Baseline

Regression analysis comparing Okaya scores to standard assessments

Correlation between Okaya (AI based) score and FAS

时间窗: Baseline

Regression analysis comparing Okaya scores to FAS

次要结局

  • Usability and patient satisfaction(Baseline)

研究者

发起方
Brijesh Patel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brijesh Patel

Assistant Professor of Clinical Medicine

Indiana University

研究点 (4)

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