Study of Custom 3D-Printed Non-invasive Ventilation Masks for Children Using Long-Term NIV Comparing Comfort, Fit, and Use to Commercial Masks in Children Aged 8 to 12

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 childrens 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.

Custom Non-invasive Ventilation Masks in Children