Trial · NCT07905378
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
NCT07905378, Not yet recruiting, Korea University Anam Hospital
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers. Trials, record NCT07905378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905378
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
- NCT number
- NCT07905378
- Status
- Not yet recruiting
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Korea University Anam Hospital
- Conditions
- Mood Disorders, Major Depressive Diorder, Bipolar Disorders, Mental Disorder
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Circular Correlation Between Fitbit Sleep-Derived eDLMO and CALERAResearch-Derived CBT Trough Midpoint | Day 1 through Day 7 | The relationship between estimated dim light melatonin onset (eDLMO), derived from sleep timing data collected using Fitbit Charge 6, and the core body temperature (CBT) trough midpoint measured using CALERAResearch will be evaluated in Study 1 participants. One circadian phase estimate will be derived for each marker during the 7-day monitoring period. The relationship between the two phase markers will be quantified using the circular-circular correlation coefficient (r), accounting for the 24-hour periodicity of clock time. The coefficient is dimensionless and ranges from -1 to 1, with values closer to 1 indicating stronger positive circular correlation. |
| Primary | Circular Correlation Between Fitbit Heart Rate Cosinor Phase and CALERAResearch-Derived CBT Trough Midpoint | Day 1 through Day 7 | The relationship between the acrophase estimated from 24-hour cosinor fitting of heart rate data collected using Fitbit Charge 6 and the core body temperature (CBT) trough midpoint measured using CALERAResearch will be evaluated in Study 1 participants. One phase estimate will be derived for each marker during the 7-day monitoring period. The relationship between the two phase markers will be quantified using the circular-circular correlation coefficient (r), accounting for the 24-hour periodicity of clock time. The coefficient is dimensionless and ranges from -1 to 1, with values closer to 1 indicating stronger positive circular correlation. |
| Primary | 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) | Agreement in circadian phase changes between Fitbit sleep-derived estimated dim light melatonin onset (eDLMO) and CALERAResearch-derived core body temperature (CBT) trough midpoint will be evaluated in 50 Study 1 participants undergoing repeat monitoring. For each marker, the signed circular phase change between the first and second monitoring periods will be calculated. Agreement will be quantified as the mean absolute circular difference between these phase changes, expressed in hours. Lower values indicate closer agreement in the direction and magnitude of phase changes, independent of systematic differences in absolute phase timing. |
| Primary | 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) | Agreement in circadian phase changes between the acrophase derived from 24-hour cosinor fitting of Fitbit Charge 6 heart rate data and the CALERAResearch-derived core body temperature (CBT) trough midpoint will be evaluated in 50 Study 1 participants undergoing repeat monitoring. For each marker, the signed circular phase change between the two monitoring periods will be calculated. Agreement will be quantified as the mean absolute circular difference between these phase changes, expressed in hours. Lower values indicate closer agreement in the direction and magnitude of phase changes, independent of systematic differences in absolute phase timing. |
| Secondary | Mean Absolute Difference in Sleep Midpoint Between Fitbit Charge 6 and CALERAResearch | Day 1 through Day 7 | Agreement between sleep midpoint derived from Fitbit Charge 6 sleep data and rest/sleep midpoint estimated from CALERAResearch raw accelerometry will be evaluated during concurrent monitoring in Study 1. The mean absolute circular difference between corresponding midpoint estimates will be calculated and reported in hours. Lower values indicate closer agreement between devices. |
| Secondary | Rate of Longitudinal Change in CALERAResearch-Derived Core Body Temperature Trough Midpoint | From study enrollment through study completion, an average of 3 weeks | Core body temperature (CBT) trough midpoint will be derived from continuous CALERAResearch measurements during successive monitoring periods in the inpatient cohort (Study 2). Signed circular phase changes will be calculated while accounting for the 24-hour periodicity of clock time. A longitudinal repeated-measures model will estimate the rate of phase change in relation to days since admission, accounting for within-participant correlation. The outcome will be reported as the estimated phase change per day, expressed in hours/day. |
| Secondary | Rate of Longitudinal Change in CALERAResearch-Derived Core Body Temperature Rhythm Amplitude | From study enrollment through study completion, an average of 3 weeks | Core body temperature (CBT) rhythm amplitude will be derived from continuous CALERAResearch measurements during successive monitoring periods in the inpatient cohort (Study 2). A linear mixed-effects model will estimate the longitudinal rate of change in CBT rhythm amplitude as a function of days since admission, accounting for repeated observations within participants. The outcome will be reported as the regression coefficient, expressed in degrees Celsius per day (°C/day). |
| Secondary | Rate of Longitudinal Change in CALERAResearch-Derived Rest-Activity Rhythm Interdaily Stability | From study enrollment through study completion, an average of 3 weeks | Interdaily stability (IS) of rest-activity rhythms will be calculated from CALERAResearch raw accelerometry during successive monitoring periods in the inpatient cohort (Study 2). IS is a dimensionless nonparametric measure of the regularity of rest-activity patterns across days, with higher values indicating greater day-to-day rhythm stability. A linear mixed-effects model will estimate the longitudinal rate of change in IS as a function of days since admission, accounting for repeated observations within participants. The outcome will be reported as the regression coefficient, expressed in IS units per day. |
| Secondary | Rate of Longitudinal Change in Absolute CBT-to-Rest/Sleep Phase Difference | From study enrollment through study completion, an average of 3 weeks | The physiological-behavioral phase difference will be defined as the absolute circular time difference between the core body temperature (CBT) trough midpoint derived from CALERAResearch temperature recordings and the rest/sleep midpoint derived from CALERAResearch raw accelerometry. The phase difference will be calculated for successive monitoring periods in the inpatient cohort (Study 2) and expressed in hours. A linear mixed-effects model will estimate its rate of change as a function of days since admission, accounting for repeated observations within participants. The outcome will be reported as the regression coefficient, expressed in hours/day. |
| Secondary | Within-Participant Regression Coefficient for BPRS Total Score and CBT-to-Rest/Sleep Phase Difference | From study enrollment through study completion, an average of 3 weeks | General psychiatric symptom severity will be assessed using the Brief Psychiatric Rating Scale (BPRS) total score at baseline and subsequent clinical assessments in the inpatient cohort (Study 2), with higher scores indicating greater psychiatric symptom severity. The physiological-behavioral phase difference will be quantified as the absolute circular time difference, expressed in hours, between the CALERAResearch-derived CBT trough midpoint and raw accelerometry-derived rest/sleep midpoint during the corresponding monitoring periods. A linear mixed-effects model will estimate the within-participant association between phase difference and BPRS total score, separating within-participant from between-participant differences. The outcome will be reported as the within-participant regression coefficient, expressed in BPRS points per hour of phase difference. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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