Calibre vs. COSMED

NCT07596108 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Pro00118791
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiorespiratory Fitness

Keywords

Cardiopulmonary Exercise Testing; VO2 Max; Exercise Physiology

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

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

Study Arms (2)

Calibre First Sequence

EXPERIMENTAL

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

COSMED First Sequence

EXPERIMENTAL

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

Interventions

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.

COSMED First Sequence

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.

Calibre First Sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Officials

• David MacLeod, M.B.B.S.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share