RPMO2 Oximeter Accuracy During Sleep 1 Trial

Running, not enrolling

Conditions studied: Obstructive Sleep Apnea

In brief

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 facts

Study ID

NCT07397780

Run by

ProSomnus Sleep Technologies

People needed

30

Starts

2026-01-22

Expected to finish

2026-07-30

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Star Sleep and Wellness — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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