Evaluating an AI Tool for Detecting Thyrotoxic States

Part of paid clinical trials in San Francisco, California.

Sponsor
THYROSCOPE INC.
Study ID
NCT07017907
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Heart rate-based AI software for detecting thyrotoxicosis — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Glandy HYPER Validation Cohort
    articipants diagnosed with Graves' disease who are either newly diagnosed or currently under treatment. All participants will wear a commercially available smartwatch (Apple or Samsung) to measure sleep heart rate, and undergo thyroid function testing (free T4 and TSH) at baseline and follow-up visits over 12 weeks. No therapeutic intervention will be applied, and data from wearable devices will be used solely for observational performance evaluation of the investigational software.

Primary Outcome Measure

F1 Score for Detection of Thyrotoxicosis Using the Investigational Software [ Time Frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Umesh MasharaniSan FranciscoCalifornia94143
Umesh Masharani, MD
[email protected]
415-353-2350

Find similar trials in San Francisco, CA

By research site
Umesh Masharani· San Francisco, CA

Related Studies