HealthyNCT06267976
Validation of the ProSomnus® RPMO2 Device
An observational study of Healthy, run by ProSomnus Sleep Technologies at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ProSomnus RPMO2
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the ProSomnus® RPMO2 Pulse Oximeter Device
The purpose of the study is to:
- 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.
- Evaluate the pulse rate performance simultaneously collected over the SpO2 range.
Read the 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
- Being tested
- ProSomnus RPMO2
- Keywords
- pulse oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSomnus RPMO2Device
The ProSomnus RPMO2 device is an intraoral reflectance pulse oximeter.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Health adult volunteers will undergo a controlled desaturation to collect data for validation of the RPMO2 device. Receives: Device: ProSomnus RPMO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 accuracy
Root-mean-square (Rms) ± 3.5 [% SpO2] over the range of 70 to 100% SaO2
Measured: 2 hours
Pulse rate accuracy
Rms within ± 3 [1/min] over the claimed range
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start10 Jun 2024
- Primary completion15 Sep 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProSomnus Sleep Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267976
- Sponsor's protocol ID
- REB23-1003
- Status last verified
- Aug 2025
- First submitted
- 12 Feb 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the ProSomnus® RPMO2 Pulse Oximeter Device
- ClinicalTrials.gov ID
- NCT06267976
- Acronym / sponsor ID
- REB23-1003
- Conditions
- Healthy
- Keywords
- pulse oximeter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ProSomnus Sleep TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: ProSomnus RPMO2Health adult volunteers will undergo a controlled desaturation to collect data for validation of the RPMO2 device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProSomnus RPMO2The ProSomnus RPMO2 device is an intraoral reflectance pulse oximeter. | Device | Healthy volunteers |
Primary outcome
SpO2 accuracy
Time frame: 2 hours
Root-mean-square (Rms) ± 3.5 [% SpO2] over the range of 70 to 100% SaO2
Pulse rate accuracy
Time frame: 2 hours
Rms within ± 3 [1/min] over the claimed range
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by ProSomnus Sleep Technologies at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 accuracy (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.