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RPMO2 Oximeter Accuracy During Sleep 1 Trial

NCT07397780 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-02-19

No results posted yet for this study

Summary

The goal of this observational study is to validate the accuracy of the RPMO2 OSA Device's oxygen desaturation index in individuals with obstructive sleep apnea versus the gold standard, in-lab polysomnography.

Participants will receive an RPMO2 OSA Device and complete one night in a sleep lab using the device in addition to the standard montage used for polysomnography.

Conditions

Interventions

DEVICE

RPMO2 OSA Device

Buccal mucosal oximeter embedded into the upper dental arch of an oral appliance used to treat obstructive sleep apnea.

Sponsors & Collaborators

  • ProSomnus Sleep Technologies

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2026-05-30
Completion
2026-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07397780 on ClinicalTrials.gov