Validation of the ProSomnus® RPMO2 Device

Healthy Clinical Trial

Official title:

Validation of the ProSomnus® RPMO2 Pulse Oximeter Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267976
• Other study ID #: REB23-1003
• Status: Recruiting
• Start date: June 15, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: ProSomnus Sleep Technologies
• Contact: Bradley Hansen
• Phone: 403-210-8925
• Email: bhanse[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• ProSomnus RPMO2
The ProSomnus RPMO2 device is an intraoral reflectance pulse oximeter.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
ProSomnus Sleep Technologies

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 accuracy	Root-mean-square (Rms) ± 3.5 [% SpO2] over the range of 70 to 100% SaO2	2 hours
Primary	Pulse rate accuracy	Rms within ± 3 [1/min] over the claimed range	2 hours