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NCT Number: NCT07596108

Calibre vs. COSMED

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.

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Key information

Conditions

Cardiorespiratory Fitness

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-55
  • Able to speak English
  • Able to provide informed consent

Exclusion criteria

  • Acute myocardial infarction
  • Unstable angina
  • Syncope
  • Uncontrolled asthma
  • Arterial desaturation at rest on room air <85%
  • Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
  • Significant pulmonary hypertension
  • Active thrombosis of the lower extremity, unless treated for at least 2 weeks prior to participation.
  • Within 2 weeks of acute symptomatic pulmonary embolus
  • Considered inappropriate to participate by Principal Investigator
  • Previously experienced a heart attack
  • Pregnancy

Treatment and study plan

COSMED Quark CPET metabolic cart

Device

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.

Calibre Biometrics

Device

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.

Primary outcomes

  1. VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED

    Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days.

    VO₂ peak measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.

  2. VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED

    Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days.

    VO₂ peak measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.

  3. Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED

    Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days

    Anaerobic threshold measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.

  4. Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED

    Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days

    Anaerobic threshold measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.

  5. VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED

    Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days

    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.

  6. VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED

    Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Correlation of Cardiopulmonary Exercise Testing (CPET) VO2 Max Parameters Between the Calibre Device and COSMED Metabolic Cart

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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