Healthy SubjectsNCT03252574
A Randomised Crossover Study to Explore the Physiological Impact of AIR+ Smart Masks on Children
A study testing A and B 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+ Smart 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?
- A and B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2016to Dec 2017
- 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 parent/legal guardian must provide the consent and assent as appropriate 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.
Singapore1 site
Innosparks Pte Ltd, 75 Ayer Rajah Crescent, #02-13
Singapore, 139953
About this study
Official title: To Explore the Physiological Impact of AIR+ Smart Masks on Children
The primary objective is to evaluate the physiological impact of AIR+ Smart 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, we will assess the general well-being and comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.
Read the detailed description
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. Innosparks Pte Ltd (formerly, ST Dynamics) (the Advanced Engineering Centre of ST Engineering) developed a new type of disposable particulate respirator (hereon referred to as AIR+ Smart Mask) that is suitable for use in both adults and children, from ages 7 and above.They also designed an optional accompanying device, the micro-ventilator, which is battery-powered and aims to extract accumulated heat, moisture, and carbon dioxide from within the mask. Innosparks Pte Ltd (formerly, ST Dynamics) have obtained the US National Institute for Occupational Safety and Health (NIOSH) N95 certification for the three sizes of masks without micro-ventilator, and Conformité Européenne's (CE) certification for the following mask specifications:• FFP1 and NIOSH approved N95 for S and M-sized AIR+ Smart Masks without micro ventilator;• FFP2 and NIOSH approved N95 for L-sized mask without micro ventilator;• FFP1 certification for S and M-sized masks with micro-ventilator, and;• FFP2 certification for the L size mask with micro-ventilator.For purposes of this research, both CE and NIOSH markings will be made for the masks trialed.As the masks were developed specifically for school-going children, this study is designed to explore whether the new disposable particulate respirator, which can be attached with a ventilator to vent out expired air within the 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 with and without the AIR+ Smart 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
- A, B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOther
AIR+ Smart Mask Only
BOther
AIR+ Smart Mask with micro-ventilator
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Other | No mask, followed by AIR+ Smart Mask only (A), then AIR+ Smart Mask with micro-ventilator (B) Receives: Other: A; Other: B |
| Sequence BA | Other | No mask, followed by AIR+ Smart Mask with micro-ventilator (B), then AIR+ Smart Mask only (A). Receives: Other: A; Other: B |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Tidal Carbon Dioxide
Measured: 75 minutes
Secondary outcomes (3)
Percent Oxygen Saturation
Measured: 75 minutes
Heart Rate
Measured: 75 minutes
Respiratory Rate
Measured: 75 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startJul 2016
- Primary completionAug 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innosparks Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Goh, A/P, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252574
- Sponsor's protocol ID
- ISPL-2015/01059
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roberge RJ, Coca A, Williams WJ, Powell JB, Palmiero AJ. Physiological impact of the N95 filtering facepiece respirator on healthcare workers. Respir Care. 2010 May;55(5):569-77.
PubMed 20420727Sinkule EJ, Powell JB, Goss FL. Evaluation of N95 respirator use with a surgical mask cover: effects on breathing resistance and inhaled carbon dioxide. Ann Occup Hyg. 2013 Apr;57(3):384-98. doi: 10.1093/annhyg/mes068. Epub 2012 Oct 29.
PubMed 23108786Ickx B, Dolomie J-0, Benalouch M et al. Arterial to End-tidal carbon dioxide tension differences in infants and children, JACR, 2155-6148 6: 511. doi:10.4172/2155-6148.1000511
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Physiological Impact of AIR+ Smart Masks on Children
- ClinicalTrials.gov ID
- NCT03252574
- Acronym / sponsor ID
- ISPL-2015/01059
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Innosparks Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, KK Women's and Children's Hospital
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Aug 2017 (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+ Smart 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, we will assess the general well-being and comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.
Detailed description
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. Innosparks Pte Ltd (formerly, ST Dynamics) (the Advanced Engineering Centre of ST Engineering) developed a new type of disposable particulate respirator (hereon referred to as AIR+ Smart Mask) that is suitable for use in both adults and children, from ages 7 and above.They also designed an optional accompanying device, the micro-ventilator, which is battery-powered and aims to extract accumulated heat, moisture, and carbon dioxide from within the mask. Innosparks Pte Ltd (formerly, ST Dynamics) have obtained the US National Institute for Occupational Safety and Health (NIOSH) N95 certification for the three sizes of masks without micro-ventilator, and Conformité Européenne's (CE) certification for the following mask specifications:• FFP1 and NIOSH approved N95 for S and M-sized AIR+ Smart Masks without micro ventilator;• FFP2 and NIOSH approved N95 for L-sized mask without micro ventilator;• FFP1 certification for S and M-sized masks with micro-ventilator, and;• FFP2 certification for the L size mask with micro-ventilator.For purposes of this research, both CE and NIOSH markings will be made for the masks trialed.As the masks were developed specifically for school-going children, this study is designed to explore whether the new disposable particulate respirator, which can be attached with a ventilator to vent out expired air within the 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 with and without the AIR+ Smart 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Other | Other: A, Other: BNo mask, followed by AIR+ Smart Mask only (A), then AIR+ Smart Mask with micro-ventilator (B) |
| Sequence BA | Other | Other: A, Other: BNo mask, followed by AIR+ Smart Mask with micro-ventilator (B), then AIR+ Smart Mask only (A). |
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 parent/legal guardian must provide the consent and assent as appropriate 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 |
|---|---|---|
| AAIR+ Smart Mask Only | Other | Sequence AB, Sequence BA |
| BAIR+ Smart Mask with micro-ventilator | Other | Sequence AB, Sequence BA |
Primary outcome
End Tidal Carbon Dioxide
Time frame: 75 minutes
3 secondary outcomes
Percent Oxygen Saturation
Time frame: 75 minutes
Heart Rate
Time frame: 75 minutes
Respiratory Rate
Time frame: 75 minutes
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 8 Aug 2018.
- Background: PubMed 20420727Roberge RJ, Coca A, Williams WJ, Powell JB, Palmiero AJ. Physiological impact of the N95 filtering facepiece respirator on healthcare workers. Respir Care. 2010 May;55(5):569-77.
- Background: PubMed 23108786Sinkule EJ, Powell JB, Goss FL. Evaluation of N95 respirator use with a surgical mask cover: effects on breathing resistance and inhaled carbon dioxide. Ann Occup Hyg. 2013 Apr;57(3):384-98. doi: 10.1093/annhyg/mes068. Epub 2012 Oct 29.
- BackgroundIckx B, Dolomie J-0, Benalouch M et al. Arterial to End-tidal carbon dioxide tension differences in infants and children, JACR, 2155-6148 6: 511. doi:10.4172/2155-6148.1000511
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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 Goh, A/P principal investigator
NUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A and B 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 8 Aug 2018. 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: 75 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252574, which also lists 3 linked publications.
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 8 Aug 2018; AzTrials last refreshed its copy on 2 Nov 2026.