Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPathway Medtech, LLC.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Smart Mask V1 System
DevicePPG-based sensors integrated into a PAP-compatible face mask to measure SpO2 and PR.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Non-Invasive (NI)Experimental treatment 1 intervention
Group B: Invasive (IN)Experimental treatment 1 intervention
Trial outcomes
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
Time frame
During each hypoxia session (90-140 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pathway Medtech, LLC.
Lead sponsor
Haku Technology
Collaborator
Source ClinicalTrials.gov