RPMO2 Oximeter Accuracy During Sleep 1 Trial

Part of paid clinical trials in Dallas, Texas.

Sponsor
ProSomnus Sleep Technologies
Study ID
NCT07397780
Status
Active Not Recruiting

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jan 22, 2026
Status verified
Feb 2026
Primary completion
May 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Agreement between 4% oxygen desaturation index between study device and polysomnography [ Time Frame: 1 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Star Sleep and WellnessDallasTexas75251-

Find similar trials in Dallas, TX

By research site
Star Sleep and Wellness· Dallas, TX

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