Custom Non-invasive Ventilation Masks in Children

NCT05336136 | Recruiting

• 1 other identifier: Pro00047768
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Noninvasive Ventilation; Child, Only; Adherence, Patient

Outcome Measures

Primary Outcomes (6)

• Change in apnea hypopnea index

  Polysomnography parameter - apnea hypopnea index

  Baseline (commercial mask study), repeated measure at 1 month (custom mask)

• Change in obstructive apnea hypopnea index

  Polysomnography parameter - obstructive apnea hypopnea index

  Baseline (commercial mask study), repeated measure at 1 month (custom mask)

• Change in oxygen desaturation index

  Polysomnography parameter - oxygen desaturation index

  Baseline (commercial mask study), repeated measure at 1 month (custom mask)

• Change in percent time with oxygen saturation less than 90%

  Polysomnography parameter - percent time with oxygen saturation less than 90%

  Baseline (commercial mask study), repeated measure at 1 month (custom mask)

• Change in percentage of nights used

  Machine download

  Two weeks of commercial versus custom mask use

• Change in average time used/night

  Machine download

  Two weeks of commercial versus custom mask use

Secondary Outcomes (5)

• Change in mask air leak (bench testing)

  Baseline (commercial mask study), repeated measure at 1 month (custom mask)

• Change in mask comfort - participant (visual likert scale, 1-9)

  End of two week of mask use of commercial versus custom mask

• Change in mask comfort - parent (visual likert scale1-9)

  End of two week of mask use of commercial versus custom mask

• Mask preference - participant (question)

  End of trial - 1 month

• Mask preference - parent (question)

  End of trial - 1 month

Study Arms (2)

Custom mask

EXPERIMENTAL

Custom mask based on 3D facial photograph for administration of non-invasive ventilation

Device: Custom mask

Current commercial mask

ACTIVE COMPARATOR

Current commercial mask used by the participant for administration of non-invasive ventilation

Device: Current commercial mask

Interventions

Custom mask DEVICE

Custom mask based on 3D facial photograph for administration of non-invasive ventilation

Custom mask

Current commercial mask DEVICE

Current commercial mask used for administration of non-invasive ventilation

Current commercial mask

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Stollery Children's Hospital: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Joanna E MacLean, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna E MacLean, MD, PhD

CONTACT

780-248-5584; joanna.maclean@ualberta.ca

Pina Collarusso, PhD

CONTACT

gcolarus@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within subject crossover

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: April 20, 2022
• Study Start: December 15, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)