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Validation of the ProSomnus® RPMO2 Device

NCT06267976 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-09-02

No results posted yet for this study

Summary

The purpose of the study is to:

1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range.

Conditions

  • Healthy

Interventions

DEVICE

ProSomnus RPMO2

The ProSomnus RPMO2 device is an intraoral reflectance pulse oximeter.

Sponsors & Collaborators

  • ProSomnus Sleep Technologies

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2024-09-15
Completion
2025-06-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267976 on ClinicalTrials.gov