Clinical Trial

RPMO2 Oximeter Accuracy During Sleep 1 Trial

Study acronym: ROADS-1
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 19, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-05.
Status change: Recruiting → Active, Not Recruiting 2026-02-18
Trial Details
NCT Number NCT07397780
Lead Sponsor ProSomnus Sleep Technologies
Conditions Obstructive Sleep Apnea
Enrollment 30 participants
Start Date 2026-01-22
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-19