Healthy SubjectsNCT07037381
A Study to Explore the Physiological Impact of AIR+ KN95 Masks on Children
A study testing KN95 mask in people with Healthy Subjects, run by Innosparks Pte Ltd. at 1 site in Singapore.
Trial summary
The primary objective is to evaluate the physiological impact of AIR+ KN95 Masks on end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate (HR) and respiratory rate (RR). Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- KN95 mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 6 May 2024to 23 May 2024
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 7 and 14 years of age (inclusive)
- Subjects and their parents or legal guardian must provide their consent/ assent to take part in this study
Who cannot join
- Subjects with any known cardiorespiratory conditions (including but not limited to the following: asthma, bronchitis, cystic fibrosis, congenital heart disease, emphysema)
- Subjects with any known medical conditions that may be exacerbated by strenuous activity, including but not limited to the following: exercise-induced asthma, lower respiratory infection (including pneumonia, bronchitis) in the past 2 weeks, anxiety disorders, diabetes, hypertension, or epilepsy/ seizure disorder
- Subjects with any physical disability from medical, orthopaedic, or neuromuscular disorders
- Subjects who have an acute upper respiratory tract infection/ moderately severe rhinitis (i.e. blocked nasal passages) on the day of the study
- Subjects who may compromise the integrity of the mask fit (e.g. those with excessive facial hair)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to evaluate the physiological impact of AIR+ KN95 Masks on end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate (HR) and respiratory rate (RR). In addition, the investigators will assess the general well-being and comfort level of the child when wearing the AIR+ KN95 Mask.
Read the detailed description
There is potential for severe haze episodes to occur in Singapore, and the main air pollutant in the event of haze is particulate matter (PM). Short-term exposure (continuous exposure to unhealthy daily average PSI levels over a period of a few days) to haze like the pattern seen in Singapore may cause irritation of the eyes, nose, and throat in healthy individuals. Haze particles can also affect the heart and lungs, especially in people who already have chronic heart or lung disease e.g., asthma, chronic obstructive pulmonary disease (COPD), or heart failure.
Haze is a perennial problem in Singapore. Commercially available disposable particulate respirators are typically certified for surgical and occupational use. The test standards are specified according to adult breathing conditions and fit. As commercially available disposable masks designed for occupational use are mainly for adults, such masks do not fit well on children, they do not serve well as protection against Particulate Matter 2.5 (PM 2.5), an air pollutant found in transboundary smoke haze.
Commercially available disposable particulate respirators are typically certified under the NIOSH and CE EN 149:2001+A1:2009 standards for surgical and occupational use. These respiratory masks are tested to filter particulate matter in the air with varying degrees of filtering efficiencies according to the respective categories, e.g. NIOSH KN95 certifies respirators to filter at least 95% of non-oil particulates. The test standards are specified according to adult breathing conditions and fit.
Children's respiratory minute volume and rate are different from adults. As commercially available disposable masks designed for occupational use are mainly for adults, such masks do not fit well on children, they do not serve well as protection against Particulate Matter 2.5 (PM 2.5). As haze is a perennial problem, and there is potential for severe haze episodes to occur again, there is a need to consider the development of disposable particulate respirator with enhanced safety and comfort specific for use in children.
ST Engineering Innosparks Pte. Ltd. developed a new type of disposable particulate respirator (hereon referred to as AIR+ KN95 Mask) that is suitable for use in both adults and children, from ages 7 and above. The masks come in S, M and L sizes, and have been tested according to the KN95 protocol for respirators.
Studies have shown that prolonged wearing of disposable particulate respirators may lead to an increase in carbon dioxide (CO2) levels in the dead space of the respirator as well as in the re-breathing of the expired air when wearing it. The increased CO2 levels may result in headaches, increased irritability, and breathing difficulty. In addition, there is some discomfort due to the accumulation of heat and humid air in the dead space of between the respirator and face. However, the mask design is based on our previous AIR+ Smart Mask specifications, which was previously evaluated in a clinical trial performed in collaboration with NUH and the data published in a peer-reviewed journal1, showing no significant increase in CO2 retention and the mask was found to be comfortable at rest and on mild exertion. The mask was commercially launched in 2015.
As the masks were developed specifically for school-going children, this study is designed to explore whether the new disposable particulate respirator is safe and effective for use in healthy children aged 7 to 14 years of age. This is through measuring the variation of carbon dioxide levels in children whilst wearing the AIR+ KN95 Mask. End-tidal carbon dioxide pressure (ETCO2) is a good indicator of arterial carbon dioxide pressure (PaCO2) in healthy adults and children and has been used for continuous direct assessment of PaCO2 in clinical contexts. The normal range of PaCO2 is from 35 - 45 mmHg. As there is a slight margin of difference between ETCO2 and PaCO2 values during measurement of about 1.6 +/- 4.3mmHg, this study defines 30 to 50mmHg as the acceptable range for ETCO2 levels.
- Conditions
- Healthy Subjects
- Being tested
- KN95 mask
- Keywords
- Respiratory Protection, Physiological Impact, Particulate Respirators, KN95 Pediatric Mask, Air Pollution, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN95 maskOther
AIR+ KN95 mask
| Study group | Role | What they receive |
|---|---|---|
| Rest followed by mild exertion without mask and while wearing KN95 mask | Experimental | All study participants (single group) underwent, Rest (Reading) with no mask (control), rest (Reading) while wearing AIR+KN95 mask (intervention) followed by mild exertion without mask (control), mild exertion with the AIR+KN95 mask (intervention) Receives: Other: KN95 mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal Carbon Dioxide
Single-use nasal cannulas used in conjunction with Nomoline™ Adapters connected to a Masimo Rad-97™ Pulse CO-Oximeter™ with NomoLine Capnography to log the End-tidal Carbon Dioxide (ETCO2), respiratory rate (RR) information, oxygen saturation (SpO2) and heart rate (HR).
Measured: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Secondary outcomes (3)
Oxygen Saturation
Single-use nasal cannulas used in conjunction with Nomoline™ Adapters connected to a Masimo Rad-97™ Pulse CO-Oximeter™ with NomoLine Capnography to log the End-tidal Carbon Dioxide (ETCO2), respiratory rate (RR) information, oxygen saturation (SpO2) and heart rate (HR).
Measured: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Respiratory Rate
Single-use nasal cannulas used in conjunction with Nomoline™ Adapters connected to a Masimo Rad-97™ Pulse CO-Oximeter™ with NomoLine Capnography to log the End-tidal Carbon Dioxide (ETCO2), respiratory rate (RR) information, oxygen saturation (SpO2) and heart rate (HR).
Measured: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Heart Rate
Single-use nasal cannulas used in conjunction with Nomoline™ Adapters connected to a Masimo Rad-97™ Pulse CO-Oximeter™ with NomoLine Capnography to log the End-tidal Carbon Dioxide (ETCO2), respiratory rate (RR) information, oxygen saturation (SpO2) and heart rate (HR).
Measured: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start6 May 2024
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innosparks Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Khoo Teck Puat-National University Children's Medical Institute, National University Health System
- Responsible party
- Sponsor
- Investigators
- Daniel YT Goh, MBBS, FRCPCH, Principal investigator, Department of Paediatrics, Khoo Teck Puat - National University Children's Medical Institute, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037381
- Sponsor's protocol ID
- ISPL - PIEC/2022/050
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only members of the study team e.g PI, con-investigator, and study coordinator, will have access to the data. Data collected will be de-identified and coded at source. Confidentiality of the data will be maintained at all times.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Explore the Physiological Impact of AIR+ KN95 Masks on Children
- ClinicalTrials.gov ID
- NCT07037381
- Acronym / sponsor ID
- ISPL - PIEC/2022/050
- Conditions
- Healthy Subjects
- Keywords
- Respiratory Protection, Physiological Impact, Particulate Respirators, KN95 Pediatric Mask, Air Pollution, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Innosparks Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Khoo Teck Puat-National University Children's Medical Institute, National University Health System
- Study start
- 6 May 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 25 Jun 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 primary objective is to evaluate the physiological impact of AIR+ KN95 Masks on end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate (HR) and respiratory rate (RR). In addition, the investigators will assess the general well-being and comfort level of the child when wearing the AIR+ KN95 Mask.
Detailed description
There is potential for severe haze episodes to occur in Singapore, and the main air pollutant in the event of haze is particulate matter (PM). Short-term exposure (continuous exposure to unhealthy daily average PSI levels over a period of a few days) to haze like the pattern seen in Singapore may cause irritation of the eyes, nose, and throat in healthy individuals. Haze particles can also affect the heart and lungs, especially in people who already have chronic heart or lung disease e.g., asthma, chronic obstructive pulmonary disease (COPD), or heart failure.
Haze is a perennial problem in Singapore. Commercially available disposable particulate respirators are typically certified for surgical and occupational use. The test standards are specified according to adult breathing conditions and fit. As commercially available disposable masks designed for occupational use are mainly for adults, such masks do not fit well on children, they do not serve well as protection against Particulate Matter 2.5 (PM 2.5), an air pollutant found in transboundary smoke haze.
Commercially available disposable particulate respirators are typically certified under the NIOSH and CE EN 149:2001+A1:2009 standards for surgical and occupational use. These respiratory masks are tested to filter particulate matter in the air with varying degrees of filtering efficiencies according to the respective categories, e.g. NIOSH KN95 certifies respirators to filter at least 95% of non-oil particulates. The test standards are specified according to adult breathing conditions and fit.
Children's respiratory minute volume and rate are different from adults. As commercially available disposable masks designed for occupational use are mainly for adults, such masks do not fit well on children, they do not serve well as protection against Particulate Matter 2.5 (PM 2.5). As haze is a perennial problem, and there is potential for severe haze episodes to occur again, there is a need to consider the development of disposable particulate respirator with enhanced safety and comfort specific for use in children.
ST Engineering Innosparks Pte. Ltd. developed a new type of disposable particulate respirator (hereon referred to as AIR+ KN95 Mask) that is suitable for use in both adults and children, from ages 7 and above. The masks come in S, M and L sizes, and have been tested according to the KN95 protocol for respirators.
Studies have shown that prolonged wearing of disposable particulate respirators may lead to an increase in carbon dioxide (CO2) levels in the dead space of the respirator as well as in the re-breathing of the expired air when wearing it. The increased CO2 levels may result in headaches, increased irritability, and breathing difficulty. In addition, there is some discomfort due to the accumulation of heat and humid air in the dead space of between the respirator and face. However, the mask design is based on our previous AIR+ Smart Mask specifications, which was previously evaluated in a clinical trial performed in collaboration with NUH and the data published in a peer-reviewed journal1, showing no significant increase in CO2 retention and the mask was found to be comfortable at rest and on mild exertion. The mask was commercially launched in 2015.
As the masks were developed specifically for school-going children, this study is designed to explore whether the new disposable particulate respirator is safe and effective for use in healthy children aged 7 to 14 years of age. This is through measuring the variation of carbon dioxide levels in children whilst wearing the AIR+ KN95 Mask. End-tidal carbon dioxide pressure (ETCO2) is a good indicator of arterial carbon dioxide pressure (PaCO2) in healthy adults and children and has been used for continuous direct assessment of PaCO2 in clinical contexts. The normal range of PaCO2 is from 35 - 45 mmHg. As there is a slight margin of difference between ETCO2 and PaCO2 values during measurement of about 1.6 +/- 4.3mmHg, this study defines 30 to 50mmHg as the acceptable range for ETCO2 levels.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rest followed by mild exertion without mask and while wearing KN95 mask | Experimental | Other: KN95 maskAll study participants (single group) underwent, Rest (Reading) with no mask (control), rest (Reading) while wearing AIR+KN95 mask (intervention) followed by mild exertion without mask (control), mild exertion with the AIR+KN95 mask (intervention) |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged between 7 and 14 years of age (inclusive)
- Subjects and their parents or legal guardian must provide their consent/ assent to take part in this study
Key exclusion criteria (5 listed)
- Subjects with any known cardiorespiratory conditions (including but not limited to the following: asthma, bronchitis, cystic fibrosis, congenital heart disease, emphysema)
- Subjects with any known medical conditions that may be exacerbated by strenuous activity, including but not limited to the following: exercise-induced asthma, lower respiratory infection (including pneumonia, bronchitis) in the past 2 weeks, anxiety disorders, diabetes, hypertension, or epilepsy/ seizure disorder
- Subjects with any physical disability from medical, orthopaedic, or neuromuscular disorders
- Subjects who have an acute upper respiratory tract infection/ moderately severe rhinitis (i.e. blocked nasal passages) on the day of the study
- Subjects who may compromise the integrity of the mask fit (e.g. those with excessive facial hair)
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 |
|---|---|---|
| KN95 maskAIR+ KN95 mask | Other | Rest followed by mild exertion without mask and while wearing KN95 mask |
Primary outcome
End-tidal Carbon Dioxide
Time frame: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Single-use nasal cannulas used in conjunction with Nomoline™ Adapters connected to a Masimo Rad-97™ Pulse CO-Oximeter™ with NomoLine Capnography to log the End-tidal Carbon Dioxide (ETCO2), respiratory rate (RR) information, oxygen saturation (SpO2) and heart rate (HR).
3 secondary outcomes
Oxygen Saturation
Time frame: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Respiratory Rate
Time frame: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Heart Rate
Time frame: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
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 27 Jun 2025.
- Individual participant dataSharing planned: No. Only members of the study team e.g PI, con-investigator, and study coordinator, will have access to the data. Data collected will be de-identified and coded at source. Confidentiality of the data will be maintained at all times.
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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.
Daniel YT Goh, MBBS, FRCPCH principal investigator
Department of Paediatrics, Khoo Teck Puat - National University Children's Medical Institute, National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KN95 mask in people with Healthy Subjects, run by Innosparks Pte Ltd. at 1 site in Singapore.
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 2 inclusion and 5 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 27 Jun 2025. 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 Singapore. 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?
End-tidal Carbon Dioxide (time frame: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes). 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 27 Jun 2025.