RPMO2 Oximeter Accuracy During Sleep 1 Trial

NCT07397780 | Active Not Recruiting FDA Device

• 1 other identifier: SP-008
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; oral appliance therapy; mandibular advancement; oximetry

Outcome Measures

Primary Outcomes (1)

• Agreement between 4% oxygen desaturation index between study device and polysomnography

  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.

  1 week

Interventions

RPMO2 OSA Device DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with obstructive sleep apnea

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

Sponsors & Collaborators

• ProSomnus Sleep Technologies: lead

Study Sites (1)

Star Sleep and Wellness

Dallas, Texas, 75251, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 9, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)