Evaluating an AI Tool for Detecting Thyrotoxic States
A legfontosabb adatok
- Hol
- San Francisco (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Umesh MasharaniSan Francisco, Egyesült ÁllamokContact: Umesh Masharani, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- THYROSCOPE INC.
- Azonosító
- NCT07017907
- A regiszteradat frissítve
- 2026. június 1.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.); Individuals with severe psychiatric disorders, substance use disorder, or alcohol dependence; 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 deemed ineligible at the discretion of the investigator for safety or ethical concerns.