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New treatment option for Sleep-disordered Breathing (SDB)
Official title Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
ClinicalTrials.gov ID: NCT07086742
What this study is testing
- What it's testing
- 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%?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people with ASA health score of I or II
- people aged between ≥ 18 and ≤ 65 years.
- people who have provided informed consent and are willing to comply with the study procedures.
You likely can't join 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.
- people known with altitude sickness.
- people who are obese (BMI ≥ 35 kg/m2).
See the full eligibility criteria
- Healthy people with ASA health score of I or II
- people aged between ≥ 18 and ≤ 65 years.
- people who have provided informed consent and are willing to comply with the study procedures.
- 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.
- people known with altitude sickness.
- people who are obese (BMI ≥ 35 kg/m2).
- people with a known history of moderate to severe heart, lung, kidney or liver disease.
- people diagnosed with moderate to severe asthma.
- people 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.
- people 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.
- people with a history of fainting or vasovagal response.
- people with a history of sensitivity or allergy to local anesthetics or disinfectants if included in the IN study.
- people diagnosed with Raynaud's disease.
- people with unacceptable collateral circulation based on examination by the investigator.
- people who are pregnant, lactating or trying to become pregnant.
- people unable or unwilling to provide informed consent or comply with study procedures.
- people with any other condition that, in the investigator's opinion, would make them unsuitable for the study.
- people who refuse to remove nail polish from their index finger.
- Volunteers not willing to remove facial make-up.
The study team makes the final eligibility decision.
Where it's taking place
- Genk, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genk, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.