Validation of the ProSomnus® RPMO2 Device

NCT06267976 | Completed FDA Device

• 1 other identifier: REB23-1003
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to:

1. 1.Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
2. 2.Evaluate the pulse rate performance simultaneously collected over the SpO2 range.

Conditions

Healthy

Keywords

pulse oximeter

Outcome Measures

Primary Outcomes (2)

• SpO2 accuracy

  Root-mean-square (Rms) ± 3.5 \[% SpO2\] over the range of 70 to 100% SaO2

  2 hours

• Pulse rate accuracy

  Rms within ± 3 \[1/min\] over the claimed range

  2 hours

Study Arms (1)

Healthy volunteers

Health adult volunteers will undergo a controlled desaturation to collect data for validation of the RPMO2 device.

Device: ProSomnus RPMO2

Interventions

ProSomnus RPMO2 DEVICE

The ProSomnus RPMO2 device is an intraoral reflectance pulse oximeter.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include volunteers who have previously been determined to be healthy enough for the study and who have signed an informed consent form and met the eligibility criteria. A minimum of 10 healthy participants will be recruited to complete the test protocol. A minimum of two participants or 15% of the participant pool (whichever is larger) will have Fitzpatrick Skin type IV, V, or VI (i.e., darkly pigmented skin).

You may qualify if:

• Male or female, aged ≥ 18 and \< 50 years.
• In good health with no evidence of medical problems.
• Ability to provide informed consent and willingness to comply with the study procedures.
• Ability to undergo controlled hypoxemia to the levels outlined in the desaturation profile.
• Adequate dentition for an oral appliance.
• Ability to breathe through the nose comfortably.

You may not qualify if:

• Obesity (BMI \> 40 kg/m2).
• Known history of heart, lung, kidney, or liver disease.
• Diagnosis of asthma or sleep apnea.
• Diagnosis of diabetes.
• Presence of a clotting disorder.
• Presence of hemoglobinopathy or history of anemia that, in the opinion of the PI, makes the individual unsuitable for participation.
• Current smoker.
• History of fainting or vasovagal response.
• History of sensitivity to local anesthesia.
• Unacceptable collateral circulation based on exam (Allen's test).
• Pregnancy or lactation.
• Resting heart rate \> 120 bpm.
• Systolic BP \> 150, diastolic BP \> 90.
• Carboxyhemoglobin level \> 3%.
• Presence of any other condition that, in the opinion of the PI, makes the individual unsuitable for participation.

Sponsors & Collaborators

• ProSomnus Sleep Technologies: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

Study Design

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

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: June 10, 2024
• Primary Completion: September 15, 2024
• Study Completion: June 30, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)