NCT05336136 Custom Non-invasive Ventilation Masks in Children
| NCT ID | NCT05336136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Noninvasive Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-12-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
One significant challenge to non-invasive ventilation (NIV) use in children is finding masks to fit a wide range of growing shapes and sizes. While the technology has improved with development of masks specifically for children, the range of options remains limited. Given the smaller size relative to adults, craniofacial abnormalities and craniofacial differences are more likely to compromise mask fit for children. A poor mask fit is uncomfortable, alters delivery of airway pressure, and, in some children, leads to failure of NIV and the need for surgical insertion of an airway in the neck to deliver positive airway pressure through a tracheostomy. This makes expanding the technology to deliver NIV vital and custom NIV masks an exciting solution.In this study, this study will enroll children who are established on long-term NIV with at least some use within 3 months of starting this therapy but who have non-optimal adherence. After consenting to participate and completing demographic and health questionnaire, participants will undergo a facial scan using stereophotogrammetry. This scan will be imported into a computer-aided design software to create a NIV mask customized to the individual face. The steps of mask testing will include: i) Bench testing to compare the leak and comfort parameters of the current commercial mask used by the participant to the custom mask: ii) Efficacy of treatment as measured by polysomonography iii) NIV compliance from machine downloads; iv) Questionnaires to assess the subjective comfort, fit, and adverse events Finally, participants and their parents/guardian will be asked which mask they prefer and why.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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, unalbe 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.
Contact & Investigator
Joanna E MacLean, MD, PhD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05336136 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Noninvasive Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05336136 currently recruiting?
Yes, NCT05336136 is actively recruiting participants. Contact the research team at joanna.maclean@ualberta.ca for enrollment information.
Where is the NCT05336136 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05336136 clinical trial?
NCT05336136 is sponsored by University of Alberta. The principal investigator is Joanna E MacLean, MD, PhD at University of Alberta. The trial plans to enroll 15 participants.