Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate

NCT07086742 | Recruiting FDA Device

• 2 other identifiers: TP-SMS-0004CIV-24-10-049534
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep-disordered Breathing (SDB); Sleep Apnea; Sleep Quality

Keywords

Pulse Oximeters; SpO2; Sleep apnea; postive air pressure

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy (Arms)

  Root mean square error (Arms) of SpO2 measured by the Smart Mask compared to SpO2 and SaO2 reference devices

  During each hypoxia session (90-140 minutes)

Study Arms (2)

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.

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.

Device: Smart Mask V1 System

Interventions

Smart Mask V1 System DEVICE

PPG-based sensors integrated into a PAP-compatible face mask to measure SpO2 and PR.

Also known as: Smart Mask, SMV1

Invasive (IN); Non-Invasive (NI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Pathway Medtech, LLC.: lead
• Haku Technology: collaborator

Study Sites (1)

Complementair Medisch Centrum (CMC) Europe

Genk, 3600, Belgium

RECRUITING

Related Links

• ISO Standard document for pulse oximeters.

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Raf De Jongh, M.D.

  Complementair Medisch Centrum (CMC) Europe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raf De Jongh, M.D.

CONTACT

+32 477 514 77; raf.dejongh@skynet.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: September 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)