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NCT07017907

Evaluating an AI Tool for Detecting Thyrotoxic States

Recruiting
Not specifiedAges 22+Observational
THYROSCOPE INC.
~15 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Heart rate-based AI software for detecting thyrotoxicosis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
F1 Score for Detection of Thyrotoxicosis Using the Investigational Software
Measured over At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total

Conditions

Graves Disease
Hyperthyroidism/Thyrotoxicosis

Explore related trials

Graves DiseaseHyperthyroidism

NCT07017907

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Umesh Masharani

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Umeshi Masharani, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Jun An
[email protected]
‭+82 10-2849-0041‬
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Adults aged 22 years or older, regardless of sex.
Individuals who are newly diagnosed with Graves' disease or currently undergoing treatment for it.
Individuals who have received sufficient explanation about the investigational software and are able to use it appropriately.
Individuals who voluntarily agree to participate in the study and have signed informed consent, either directly or via a legally authorized representative.

Exclusion

Individuals with cardiac conditions such as arrhythmia or heart failure.
Individuals taking medications that significantly affect heart rate, including antiarrhythmics or antihistamines. (Intermittent short-acting beta-blockers are allowed.)
Pregnant or breastfeeding individuals, or those planning pregnancy during the study period or not using appropriate contraception.
Individuals with significant comorbidities that interfere with follow-up or study compliance.
Individuals with severe psychiatric disorders, substance use disorder, or alcohol dependence.
Individuals deemed ineligible at the discretion of the investigator for safety or ethical concerns.

What this trial measures

  • F1 Score for Detection of Thyrotoxicosis Using the Investigational SoftwareAt weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total

    The F1 score will be calculated to evaluate the performance of the AI-based investigational software in detecting thyrotoxic states. The device's output, derived from wearable heart rate data and reference data, will be compared against the diagnosis based on serum free T4 concentration at each time point. Each participant contributes multiple data pairs (evaluation-reference combinations) based on serial visits (V2-V5), and the F1 score will be calculated for each case and summarized across all cases.