NCT06267976

Validation of the ProSomnus® RPMO2 Device

Validation of the ProSomnus® RPMO2 Pulse Oximeter Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: ProSomnus Sleep Technologies · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to: 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. Evaluate the pulse rate performance simultaneously collected over the SpO2 range.

Detailed description

Testing will be performed with participants semi-recumbent, under non-motion conditions. SpO2 accuracy of the test device will be determined by a controlled desaturation study with measurements taken over the full range of SaO2 values for which accuracy is to be claimed +3% of the lower value and -3% of the upper value. Participants will be desaturated to achieve six plateaus between 100-70% SaO2. Arterial blood draws within the hypoxic plateaus will be performed, with draws occurring no less than 30 seconds after reaching a plateau and no less than 20 seconds apart. Five blood draws will be taken at each plateau. Plateaus will be determined using the reference transmittance pulse oximeter and are defined as a change in SpO2 on the reference pulse oximeter of no more than 1% over a duration of 20 seconds. Sampling will not continue if the blood oxygen saturation destabilizes between blood draws. Time in low O2 saturation decades (i.e., 70-80% and 80-90%) will be limited to the minimum amount of time required to obtain test data and will not exceed 10 minutes. The saturation level at each plateau and the number of plateaus may vary among participants. Arterial pressure, ECG, heart rate, EtCO2, respiratory rate, and FiO2 will be monitored during testing. Extra samples may be collected at the discretion of the PI. The controlled desaturation protocol is expected to take approximately 30 to 60 minutes.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	ProSomnus RPMO2	The ProSomnus RPMO2 device is an intraoral reflectance pulse oximeter.

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-09-15
• Completion: 2025-06-30
• First posted: 2024-02-20
• Last updated: 2025-09-02

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study