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Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Sponsor: Korea University Anam Hospital
Summary
This single-site prospective observational study aims to validate wearable-derived circadian and behavioral rhythm biomarkers using continuous core body temperature and raw accelerometry measurements and to explore longitudinal changes in circadian and rest-activity rhythms in psychiatric inpatients. The study consists of two complementary substudies. Study 1 will enroll 150 outpatients and community participants, including 75 patients with major depressive disorder or bipolar I/II disorder and 75 healthy controls. Participants will simultaneously wear a CALERAResearch core body temperature sensor and a Fitbit Charge 6 for approximately 7 days. Agreement between Fitbit-derived circadian and sleep/activity rhythm features and CALERAResearch-derived core body temperature and raw accelerometry markers will be evaluated. A subset of 50 participants will undergo a second measurement at least 1 month later to assess test-retest reliability. Study 2 will enroll 50 psychiatric inpatients irrespective of final diagnosis. Participants will continuously wear CALERAResearch and Fitbit devices from shortly after admission through the inpatient observation period, with CALERAResearch sensors replaced approximately every 5-7 days. Longitudinal changes in core body temperature rhythms, rest-activity rhythms, and physiological-behavioral rhythm alignment will be examined in relation to changes in psychiatric symptoms.
Official title: Validation of Wearable Core Body Temperature Signal-Based Circadian Rhythm Digital Biomarkers
Key Details
Gender
All
Age Range
19 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-11-01
Completion Date
2027-12-31
Last Updated
2026-10-29
Healthy Volunteers
Yes