Sleep-disordered Breathing (SDB)SMV1: PPGNCT07086742
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
A study testing Smart Mask V1 System in people with Sleep-disordered Breathing (SDB) and Sleep Apnea, run by Pathway Medtech, LLC. at 1 site in Belgium.
Trial summary
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- What is being tested?
- Smart Mask V1 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jul 2025to 23 Nov 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects with ASA health score of I or II
- Subjects aged between ≥ 18 and ≤ 65 years.
- Subjects who have provided informed consent and are willing to comply with the study procedures.
Who cannot join
- Heavy smokers or individuals exposed to high levels of carbon monoxide resulting in elevated carboxyhemoglobin levels.
- Individuals with conditions that result in elevated methemoglobin levels.
- Individuals with hypoxia (SpO2 < 95% at 21% O2).
- Severe claustrophobia.
- Subjects known with altitude sickness.
- Subjects who are obese (BMI ≥ 35 kg/m2).
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- Subjects with a known history of moderate to severe heart, lung, kidney or liver disease.
- Subjects diagnosed with moderate to severe asthma.
- Subjects with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, that in the investigator's opinion, would make them unsuitable for study participation.
- Subjects with any other serious systemic illness.
- Any injury, deformity, or abnormality at the sensor sites that, in the investigator's opinion, would interfere with the correct functioning of the test or reference devices.
- Subjects with a history of fainting or vasovagal response.
- Subjects with a history of sensitivity or allergy to local anesthetics or disinfectants if included in the IN study.
- Subjects diagnosed with Raynaud's disease.
- Subjects with unacceptable collateral circulation based on examination by the investigator.
- Subjects who are pregnant, lactating or trying to become pregnant.
- Subjects unable or unwilling to provide informed consent or comply with study procedures.
- Subjects with any other condition that, in the investigator's opinion, would make them unsuitable for the study.
- Subjects who refuse to remove nail polish from their index finger.
- Volunteers not willing to remove facial make-up.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65.
More specifically, the study is directed at answering the following questions:
Read more
- Can the Smart Mask accurately measure SpO2 levels compared to established reference devices (reference oximeters, blood gas) throughout the range of SpO2 ~ 70 - 100%?
- Can the Smart Mask accurately measure PR during the same conditions?
- Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR.
The following reference devices will be used in the study:
- An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N)
- A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples.
Study participants will:
- Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down
- Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely.
- In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.
Read the detailed description
This clinical study evaluates the Smart Mask V1 System, a medical device designed to measure blood oxygen saturation (SpO2) and pulse rate (PR) using reflective photoplethysmography (PPG) sensors integrated into a face mask intended for use with positive airway pressure (PAP) therapy. The study aims to validate the accuracy of the Smart Mask's optical measurements under controlled, progressive hypoxia conditions in healthy adult volunteers.
The investigation is divided into two sequential phases; Non-Invasive (NI) and Invasive (IN) Study. All study sessions are conducted at the Complementary Medical Centre (CMC) in Genk, Belgium, within a certified normobaric hypoxia room. This room is sealed and climate-controlled, equipped with oxygen and carbon dioxide sensors to maintain a stable and safe hypoxic environment.
Hypoxia is induced gradually to reduce any discomfort or potential risk to participants. Comprehensive safety protocols are in place to protect volunteers. These include medical screening and obtaining informed consent prior to enrollment, as well as real-time monitoring by trained medical staff throughout the exposure. Immediate exit protocols are activated if a participant's SpO2 falls below 73% or if symptoms of acute mountain sickness are observed. Emergency oxygen and resuscitation equipment are readily available on-site. Additionally, participants are reminded that they may withdraw from the study at any time without penalty.
- Conditions
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- Being tested
- Smart Mask V1 System
- Keywords
- Pulse Oximeters, SpO2, Sleep apnea, postive air pressure
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Mask V1 SystemDevice
Also called Smart Mask, SMV1
PPG-based sensors integrated into a PAP-compatible face mask to measure SpO2 and PR.
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive (NI) | Experimental | The Non-Invasive (NI) study is designed to calibrate the Smart Mask's algorithms using data collected from healthy volunteers exposed to controlled, progressive hypoxia. During the study, participants lie in a supine position in a normobaric hypoxia room while breathing room air with gradually reduced oxygen levels, with the fraction of inspired oxygen (FiO2) decreasing from approximately 21% to as low as 9.5%. The Smart Mask derives SpO2 values from reflected light signals detected by its integrated sensors. Simultaneously, a benchmark pulse oximeter (Nellcor PM10N), worn on the finger, provides reference SpO2 and pulse rate (PR) values for algorithm calibration. Data from reference device are used to refine the conversion of raw photoplethysmography (PPG) signals into SpO2 and PR readings. This phase serves as a feasibility study and is a prerequisite for advancing to subsequent phase. 12 healthy subjects will be enrolled in this study. Receives: Device: Smart Mask V1 System |
| Invasive (IN) | Experimental | If the Non-Invasive (NI) phase demonstrates feasibility, the Invasive (IN) study will follow to validate the Smart Mask's measurements against a gold-standard method. This phase involves arterial blood gas analysis to directly measure arterial oxygen saturation (SaO2) using CO-oximetry. Participants undergo the same progressive hypoxia protocol within a controlled hypoxia room. An indwelling radial artery catheter is inserted to allow periodic arterial blood sampling at five predefined oxygen plateaus. The SaO2 values obtained from the CO-oximeter reference device (ABL90 FLEX) are then compared to the SpO2 values calculated by the Smart Mask. 24 healthy volunteers will be enrolled in this phase. Receives: Device: Smart Mask V1 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy (Arms)
Root mean square error (Arms) of SpO2 measured by the Smart Mask compared to SpO2 and SaO2 reference devices
Measured: During each hypoxia session (90-140 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start20 Jul 2025
- Primary completion23 Nov 2025
- Study completion23 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered Breathing (SDB)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study has two Phases, both conducted using a standard 'breathe down' protocol featuring hypoxia room wherein oxygen levels are varied in 'plateaus' so that subjects' SpO2 levels are sequentially dropped from around 100% - 70% SpO2. In the first Phase, study subjects will be measured with Smart Mask, and their results (SpO2, PR) will be compared to a reference oximeter to develop a calibration for SpO2 measurements. In the second Phase, using this calibration, study subjects will be measured with Smart Mask, and their results (SpO2 only) will be compared to the CO-oximeter. For this second Phase, Smart Mask's measurements of PR will be compared to those from the reference oximeter.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathway Medtech, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Haku Technology
- Responsible party
- Sponsor
- Investigators
- Raf De Jongh, M.D., Principal investigator, Complementair Medisch Centrum (CMC) Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086742
- Sponsor's protocol ID
- TP-SMS-0004
- Other IDs
- CIV-24-10-049534
- Acronym
- SMV1: PPG
- Status last verified
- Jun 2025
- First submitted
- 18 Jul 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data collected during the study will be specifically used to develop Smart Mask, a device intended to be commercialized by the study sponsor. Thus, there does not appear to be any value or reason to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
- ClinicalTrials.gov ID
- NCT07086742
- Acronym / sponsor ID
- SMV1: PPG / TP-SMS-0004
- Conditions
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- Keywords
- Pulse Oximeters, SpO2, Sleep apnea, postive air pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Pathway Medtech, LLC.Industry (pharma, biotech, devices)
- Collaborators
- Haku Technology
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 23 Nov 2025 (actual)
- First posted
- 25 Jul 2025 (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 goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65.
More specifically, the study is directed at answering the following questions:
- Can the Smart Mask accurately measure SpO2 levels compared to established reference devices (reference oximeters, blood gas) throughout the range of SpO2 ~ 70 - 100%?
- Can the Smart Mask accurately measure PR during the same conditions?
- Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR.
The following reference devices will be used in the study:
- An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N)
- A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples.
Study participants will:
- Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down
- Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely.
- In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.
Detailed description
This clinical study evaluates the Smart Mask V1 System, a medical device designed to measure blood oxygen saturation (SpO2) and pulse rate (PR) using reflective photoplethysmography (PPG) sensors integrated into a face mask intended for use with positive airway pressure (PAP) therapy. The study aims to validate the accuracy of the Smart Mask's optical measurements under controlled, progressive hypoxia conditions in healthy adult volunteers.
The investigation is divided into two sequential phases; Non-Invasive (NI) and Invasive (IN) Study. All study sessions are conducted at the Complementary Medical Centre (CMC) in Genk, Belgium, within a certified normobaric hypoxia room. This room is sealed and climate-controlled, equipped with oxygen and carbon dioxide sensors to maintain a stable and safe hypoxic environment.
Hypoxia is induced gradually to reduce any discomfort or potential risk to participants. Comprehensive safety protocols are in place to protect volunteers. These include medical screening and obtaining informed consent prior to enrollment, as well as real-time monitoring by trained medical staff throughout the exposure. Immediate exit protocols are activated if a participant's SpO2 falls below 73% or if symptoms of acute mountain sickness are observed. Emergency oxygen and resuscitation equipment are readily available on-site. Additionally, participants are reminded that they may withdraw from the study at any time without penalty.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study has two Phases, both conducted using a standard 'breathe down' protocol featuring hypoxia room wherein oxygen levels are varied in 'plateaus' so that subjects' SpO2 levels are sequentially dropped from around 100% - 70% SpO2. In the first Phase, study subjects will be measured with Smart Mask, and their results (SpO2, PR) will be compared to a reference oximeter to develop a calibration for SpO2 measurements. In the second Phase, using this calibration, study subjects will be measured with Smart Mask, and their results (SpO2 only) will be compared to the CO-oximeter. For this second Phase, Smart Mask's measurements of PR will be compared to those from the reference oximeter.
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive (NI) | Experimental | Device: Smart Mask V1 SystemThe Non-Invasive (NI) study is designed to calibrate the Smart Mask's algorithms using data collected from healthy volunteers exposed to controlled, progressive hypoxia. During the study, participants lie in a supine position in a normobaric hypoxia room while breathing room air with gradually reduced oxygen levels, with the fraction of inspired oxygen (FiO2) decreasing from approximately 21% to as low as 9.5%. The Smart Mask derives SpO2 values from reflected light signals detected by its integrated sensors. Simultaneously, a benchmark pulse oximeter (Nellcor PM10N), worn on the finger, provides reference SpO2 and pulse rate (PR) values for algorithm calibration. Data from reference device are used to refine the conversion of raw photoplethysmography (PPG) signals into SpO2 and PR readings. This phase serves as a feasibility study and is a prerequisite for advancing to subsequent phase. 12 healthy subjects will be enrolled in this study. |
| Invasive (IN) | Experimental | Device: Smart Mask V1 SystemIf the Non-Invasive (NI) phase demonstrates feasibility, the Invasive (IN) study will follow to validate the Smart Mask's measurements against a gold-standard method. This phase involves arterial blood gas analysis to directly measure arterial oxygen saturation (SaO2) using CO-oximetry. Participants undergo the same progressive hypoxia protocol within a controlled hypoxia room. An indwelling radial artery catheter is inserted to allow periodic arterial blood sampling at five predefined oxygen plateaus. The SaO2 values obtained from the CO-oximeter reference device (ABL90 FLEX) are then compared to the SpO2 values calculated by the Smart Mask. 24 healthy volunteers will be enrolled in this phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects with ASA health score of I or II
- Subjects aged between ≥ 18 and ≤ 65 years.
- Subjects who have provided informed consent and are willing to comply with the study procedures.
Key exclusion criteria (20 listed)
- Heavy smokers or individuals exposed to high levels of carbon monoxide resulting in elevated carboxyhemoglobin levels.
- Individuals with conditions that result in elevated methemoglobin levels.
- Individuals with hypoxia (SpO2 < 95% at 21% O2).
- Severe claustrophobia.
- Subjects known with altitude sickness.
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 |
|---|---|---|
| Smart Mask V1 SystemAlso: Smart Mask, SMV1PPG-based sensors integrated into a PAP-compatible face mask to measure SpO2 and PR. | Device | Invasive (IN), Non-Invasive (NI) |
Primary outcome
SpO2 Accuracy (Arms)
Time frame: During each hypoxia session (90-140 minutes)
Root mean square error (Arms) of SpO2 measured by the Smart Mask compared to SpO2 and SaO2 reference devices
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 17 Sep 2026.
- Individual participant dataSharing planned: No. Data collected during the study will be specifically used to develop Smart Mask, a device intended to be commercialized by the study sponsor. Thus, there does not appear to be any value or reason to share IPD.
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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.
Raf De Jongh, M.D. principal investigator
Complementair Medisch Centrum (CMC) Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Mask V1 System in people with Sleep-disordered Breathing (SDB) and Sleep Apnea, run by Pathway Medtech, LLC. at 1 site in Belgium.
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 3 inclusion and 20 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 17 Sep 2026. 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 Belgium. 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 (Arms) (time frame: During each hypoxia session (90-140 minutes)). 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 17 Sep 2026.