An interventional study of COSMED Quark CPET metabolic cart and Calibre Biometrics in Cardiorespiratory Fitness, sponsored by Duke University. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Duke University · Not applicable, Interventional, and Other
This study evaluates agreement between the Calibre device and the COSMED Quark CPET system for measurement of cardiorespiratory fitness parameters during maximal exercise testing in adults aged 18-55 years.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants undergo cardiopulmonary exercise testing using the investigational Calibre device during Visit 1, followed by testing with the COSMED Quark CPET reference system during Visit 2 (at least 2 days later).
Device: Calibre Biometrics
Participants undergo cardiopulmonary exercise testing using the COSMED Quark CPET reference system during Visit 1, followed by testing with the investigational Calibre device during Visit 2 (at least 2 days later).
Device: COSMED Quark CPET metabolic cart
FDA-cleared cardiopulmonary exercise testing (CPET) metabolic cart used as the reference comparator for measurement of respiratory gas exchange and ventilatory parameters during ramp cycle ergometry. Participants wear a facemask connected to the system for breath-by-breath measurement of oxygen consumption (VO2), carbon dioxide production (VCO2), minute ventilation (VE), anaerobic threshold, and ventilatory efficiency during maximal exercise testing.
Investigational wearable facemask device with integrated sensors for breath-by-breath measurement of respiratory gas exchange and ventilatory parameters during cardiopulmonary exercise testing, evaluated against the COSMED Quark CPET reference system.
VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
VO₂ peak measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days.
VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
VO₂ peak measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days.
Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Anaerobic threshold measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days
Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
Anaerobic threshold measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days
VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days
VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Duke University