Evaluating an AI Tool for Detecting Thyrotoxic States (NCT07017907) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating an AI Tool for Detecting Thyrotoxic States
United States15 participantsStarted 2026-01-09
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
F1 Score for Detection of Thyrotoxicosis Using the Investigational Software
Timeframe: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total