NCT07017907
Evaluating an AI Tool for Detecting Thyrotoxic States
Recruiting
Not specifiedAges 22+ObservationalTHYROSCOPE 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
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Umeshi Masharani, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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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.