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Mouth oximeter put to the test: can it measure oxygen correctly?

NCT ID NCT06267976

Diagnosis Sponsor: ProSomnus Sleep Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the ProSomnus RPMO2, a small device worn inside the mouth that measures oxygen levels and pulse rate. Researchers compared its readings to standard blood tests in 12 healthy adults. The goal was to see if the device is accurate enough for medical use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ProSomnus RPMO2 device (intraoral pulse oximeter)
What this could lead to
If accurate, this device could offer a new way to monitor oxygen levels from inside the mouth, potentially useful for sleep studies or other monitoring.
What could go wrong
This is a small, early validation study in only 12 healthy people, not patients. The device may not perform as well in real-world conditions or in people with health issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • University of Calgary

    Calgary, Alberta, T2N4N1, Canada

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