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Calibre vs. COSMED

16 juni 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 juli 2027

Studieregistreringsdatum

Först inskickad

5 maj 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • Pro00118791

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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