Actively Recruiting
Custom Non-invasive Ventilation Masks in Children with Sub-Optimal Adherence Using Long-Term NIV
Led by University of Alberta · Updated on 2026-03-16
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
S
Stollery Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate custom non-invasive ventilation (NIV) masks designed for children aged 8 to 12 who are already using NIV but have sub-optimal adherence. The study addresses challenges in fitting NIV masks to children's unique facial shapes and sizes, especially those with craniofacial differences, which can cause discomfort and treatment failure. The goal is to compare the effectiveness, comfort, and adherence of custom masks versus current commercial masks. Participants will have a 3D facial scan taken using stereophotogrammetry to create a custom NIV mask specific to their facial features. The study uses a crossover design where each child will try both their current commercial mask and the custom mask. Each mask will be tested for fit, leak, and comfort in a bench test, followed by a polysomnography to measure treatment efficacy. Participants will use each mask for two weeks with monitoring of usage and comfort, separated by a two-week washout period. Throughout the study, children and their parents will complete questionnaires on mask comfort, fit, and any adverse events, and their NIV machine usage will be tracked. The primary outcomes include changes in apnea indices, oxygen saturation, and mask use time. At study end, participants and their guardians will state their mask preference. Safety and ongoing use decisions will involve the clinical NIV team. Total participation duration involves facial scanning, mask testing, and two 2-week mask use periods with follow-ups.
CONDITIONS
Brief Title
Custom Non-invasive Ventilation Masks in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children between 8-12 years of age
- Followed clinically by the Non-invasive ventilation clinic at the Stollery Children's Hospital
- Established on non-invasive ventilation as part of their treatment plan.
You will not qualify if you...
- Children with developmental or physical disabilities that would prevent their successful completion of the study protocol (e.g., non-verbal, unable to follow 3-step commands, unable to lie still for 20 min).
- Children whose parent/guardian are unable to provide consent because of an inability to read the study documents in English.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 45 minutes
Participants undergo fit testing to compare the custom mask to their current commercial mask by assessing mask leak and comfort at different pressures and tightness levels while seated.
1 visit (in-person)
Duration - Approximately 10 weeks including washout periods
Participants use each mask (custom and commercial) for two weeks while compliance and comfort are monitored. After each 2-week period, participants and their parent/guardian complete questionnaires about mask comfort, fit, and any adverse events. There is a minimum 2-week washout period between mask trials where participants use their commercial mask without monitoring.
2 in-person polysomnography visits and multiple compliance monitoring periods over 2-week intervals per mask
Duration - 1 visit at end of study
At the end of the trial, participants and their parent/guardian discuss mask preference and the decision about ongoing mask use is made with the clinical team.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
Actively Recruiting
Research Team
J
Joanna E MacLean, MD, PhD
P
Pina Collarusso, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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