Depression DisordersNCT07218263
AI Platform for Fatigue and Depression Detection
A study testing AI-enabled Okaya platform in people with Depression Disorders and Fatigue Symptom, run by Brijesh Patel at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Disorders, Fatigue Symptom, Cardiovascular
- What is being tested?
- AI-enabled Okaya platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, English-speaking, able to consent
Who cannot join
- Active substance use, nonverbal, cognitive disability, active suicidal/homicidal ideation
- English is not primary language or requires a translator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health - Methodist Hospital
Indianapolis, Indiana, 46202
Indiana University Health - University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Efficacy of a Novel Web-based Fatigue and Cognitive Assessment Platform in Detecting Fatigue and Depression
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.
Read the 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.
- Conditions
- Depression Disorders, Fatigue Symptom, Cardiovascular
- Being tested
- AI-enabled Okaya platform
- Keywords
- Fatigue, Depression, Artificial Intelligence
- Medical subject headings
- Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled Okaya platformDiagnostic test
AI-based conversational assessment using facial and vocal features to evaluate fatigue and depression.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Group | Experimental | Participants will complete PHQ-9, FAS, and Okaya assessments. Receives: Diagnostic Test: AI-enabled Okaya platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Okaya (AI based) score and PHQ-9
Regression analysis comparing Okaya scores to PHQ-9
Measured: Baseline
Correlation between Okaya (AI) based score and PHQ-9 and FAS
Regression analysis comparing Okaya scores to standard assessments
Measured: Baseline
Correlation between Okaya (AI based) score and FAS
Regression analysis comparing Okaya scores to FAS
Measured: Baseline
Secondary outcomes (1)
Usability and patient satisfaction
Ease-of-use ratings on the Okaya platform
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start22 Dec 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brijesh Patel
- Sponsor type
- University, hospital or other
- Collaborators
- SmartTec Inc
- Responsible party
- Sponsor-investigator, Brijesh Patel, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218263
- Sponsor's protocol ID
- IU-Okaya-2025
- Other IDs
- IRB #25854
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Web-based Fatigue and Cognitive Assessment Platform in Detecting Fatigue and Depression
- ClinicalTrials.gov ID
- NCT07218263
- Acronym / sponsor ID
- IU-Okaya-2025
- Conditions
- Depression Disorders, Fatigue Symptom, Cardiovascular
- Keywords
- Fatigue, Depression, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brijesh PatelUniversity, hospital or other
- Collaborators
- SmartTec Inc
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment Group | Experimental | Diagnostic Test: AI-enabled Okaya platformParticipants will complete PHQ-9, FAS, and Okaya assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18, English-speaking, able to consent
Key exclusion criteria (2 listed)
- Active substance use, nonverbal, cognitive disability, active suicidal/homicidal ideation
- English is not primary language or requires a translator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled Okaya platformAI-based conversational assessment using facial and vocal features to evaluate fatigue and depression. | Diagnostic test | Assessment Group |
Primary outcome
Correlation between Okaya (AI based) score and PHQ-9
Time frame: Baseline
Regression analysis comparing Okaya scores to PHQ-9
Correlation between Okaya (AI) based score and PHQ-9 and FAS
Time frame: Baseline
Regression analysis comparing Okaya scores to standard assessments
Correlation between Okaya (AI based) score and FAS
Time frame: Baseline
Regression analysis comparing Okaya scores to FAS
1 secondary outcome
Usability and patient satisfaction
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled Okaya platform in people with Depression Disorders and Fatigue Symptom, run by Brijesh Patel at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Okaya (AI based) score and PHQ-9 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.