Calibre vs. COSMED
ConditionCardiorespiratory Fitness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-55
Able to speak English
Able to provide informed consent
Disqualifiers
Acute myocardial infarction
Unstable angina
Syncope
Uncontrolled asthma
Trial design
Design model
Crossover
Treatments tested in this trial
COSMED Quark CPET metabolic cart
DeviceFDA-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.
Calibre Biometrics
DeviceInvestigational 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Calibre First SequenceExperimental treatment 1 intervention
Group B: COSMED First SequenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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 days4
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 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: