RPMO2 Oximeter Accuracy During Sleep 1 Trial

NCT07397780 · tracked via the Priya Life Science USA tracker

Sponsor

ProSomnus Sleep Technologies

Phase

Observational

Started

2026-01-22

Last updated

2026-02-19

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

RPMO2 OSA Device

RPMO2 OSA Device: Buccal mucosal oximeter embedded into the upper dental arch of an oral appliance used to treat obstructive sleep apnea.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 years or older * Diagnosed with obstructive sleep apnea (per American Academy of Sleep Medicine's definition) * Adequate dentition for oral appliance therapy * Ability to refrain from the use of OSA therapy other than the study device for the week prior to the in-lab sleep study Exclusion Criteria: * Non-respiratory sleep disorders or environmental or personal factors that preclude the accuracy, acquisition, or interpretation of in-lab polysomnography * Pregnancy * In the opinion of the principal investigator, unsuitable for participation in the study

Primary outcome measure(s)

Agreement between 4% oxygen desaturation index between study device and polysomnography — 1 week
The primary study endpoint is the paired difference in 4% ODI between the study device and polysomnography (PSG). A paired design will be used to test agreement of 4% ODI as measured using the study device and manually scored PSG simultaneously. The Bland-Altman 95% limits of agreement (LoA) and their 95% confidence intervals (CI) for the LoA will be calculated. The maximum absolute value of the CIs will be compared to the maximum allowable difference. Agreement will be concluded if the maximum absolute value of the CIs is \< 19.

Trial sites (1)

Facility	City	Region	Status
Star Sleep and Wellness	Dallas	Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07397780 on ClinicalTrials.gov ↗ ← All trials in the USA