A Study to Explore the Physiological Impact of AIR+ KN95 Masks on Children

NCT07037381 | Completed DMC

• 1 other identifier: ISPL - PIEC/2022/050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). In addition, the investigators will assess the general well-being and comfort level of the child when wearing the AIR+ KN95 Mask.

Conditions

Healthy Subjects

Keywords

Respiratory Protection; Physiological Impact; Particulate Respirators; KN95 Pediatric Mask; Air Pollution; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  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

Study Arms (1)

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)

Other: KN95 mask

Interventions

KN95 mask OTHER

AIR+ KN95 mask

Rest followed by mild exertion without mask and while wearing KN95 mask

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Innosparks Pte Ltd.: lead
• Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore: collaborator
• Khoo Teck Puat-National University Children's Medical Institute, National University Health System: collaborator

Study Sites (1)

ST Engineering Innosparks Pte Ltd

Singapore, 528553, Singapore

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel YT Goh, MBBS, FRCPCH

  Department of Paediatrics, Khoo Teck Puat - National University Children's Medical Institute, National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 25, 2025
• Study Start: May 6, 2024
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)