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Calibre vs. COSMED

16. juni 2026 oppdatert av: Duke University

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Calibre First Sequence
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).
Enhet: Calibre Biometrics
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.
Eksperimentell: COSMED First Sequence
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).
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
During CPET testing across Visit 1 and Visit 2, up to 7 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Etterforskere

  • Hovedetterforsker: David MacLeod, M.B.B.S., Duke University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • Pro00118791

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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