Status:
COMPLETED
A Randomised Crossover Study to Explore the Physiological Impact of AIR+ Smart Masks on Children
Lead Sponsor:
Innosparks Pte Ltd.
Collaborating Sponsors:
National University Hospital, Singapore
KK Women's and Children's Hospital
Conditions:
Healthy Subjects
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief 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 physio...
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-breathin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03252574
Start Date
July 1 2016
End Date
December 1 2017
Last Update
August 8 2018
Active Locations (1)
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1
Innosparks Pte Ltd, 75 Ayer Rajah Crescent, #02-13
Singapore, Singapore, 139953