Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluating an AI Tool for Detecting Thyrotoxic States
Sponsor: THYROSCOPE INC.
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.
Official title: Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
15
Start Date
2025-07-01
Completion Date
2026-12-31
Last Updated
2025-06-12
Healthy Volunteers
No
Interventions
Heart rate-based AI software for detecting thyrotoxicosis
A software-based investigational medical device that uses artificial intelligence to detect the thyrotoxic state in patients with hyperthyroidism. The device analyzes resting heart rate data collected from wearable devices along with thyroid function test results (free T4 and TSH). The device is not FDA-approved and will be used solely for observational performance evaluation without influencing clinical care.