NCT07017907 Evaluating an AI Tool for Detecting Thyrotoxic States
| NCT ID | NCT07017907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | THYROSCOPE INC. |
| Condition | Graves Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2026-01-09 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational study aims to evaluate the performance of a software-based medical device, Glandy HYPER, in detecting the thyrotoxic state in patients with hyperthyroidism. The device utilizes heart rate data collected from commercially available wearable devices and compares it with thyroid function test results. The study will enroll patients diagnosed with Graves' disease, monitoring their heart rate during sleep and correlating these measurements with free T4 levels obtained through serial blood testing. No investigational device output will be disclosed to participants, and the study will not alter standard clinical care.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Umeshi Masharani, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07017907 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07017907 currently recruiting?
Yes, NCT07017907 is actively recruiting participants. Contact the research team at jun.an@thyroscope.com for enrollment information.
Where is the NCT07017907 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07017907 clinical trial?
NCT07017907 is sponsored by THYROSCOPE INC.. The principal investigator is Umeshi Masharani, MD at University of California, San Francisco. The trial plans to enroll 15 participants.