RPMO2 Oximeter Accuracy During Sleep 1 Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
Texas
Star Sleep and Wellness
RECRUITING
Dallas
Contact Information
Primary
Erin Mosca
emosca@prosomnus.com
925-803-8643
Time Frame
Start Date: 2026-01-30
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Leads: ProSomnus Sleep Technologies

This content was sourced from clinicaltrials.gov