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Life sciences · Observational Study
ClinicalTrials.gov · October 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07905378). This is a study registration, not published results. Lead sponsor: Korea University Anam Hospital. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Mood Disorders, Major Depressive Diorder, Bipolar Disorders, Mental Disorder. Primary outcome measures: Circular Correlation Between Fitbit Sleep-Derived eDLMO and CALERAResearch-Derived CBT Trough Midpoint , Day 1 through Day 7; Circular Correlation Between Fitbit Heart Rate Cosinor Phase and CALERAResearch-Derived CBT Trough Midpoint , Day 1 through Day 7; Mean Absolute Difference in Phase Changes Between Fitbit Sleep-Derived eDLMO and CALERAResearch-Derived CBT Trough Midpoint , First 7-day monitoring period (Days 1-7) and second 7-day monitoring period (an average of 3 months after baseline); Mean Absolute Difference in Phase Changes Between Fitbit Heart Rate Cosinor Phase and CALERAResearch-Derived CBT Trough Midpoint , First 7-day monitoring period (Days 1-7) and second 7-day monitoring period (an average of 3 months after baseline). Brief 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.