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ACTIVE NOT RECRUITING
NCT07397780

RPMO2 Oximeter Accuracy During Sleep 1 Trial

Sponsor: ProSomnus Sleep Technologies

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-01-22

Completion Date

2026-07-30

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

DEVICE

RPMO2 OSA Device

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

Locations (1)

Star Sleep and Wellness

Dallas, Texas, United States