Custom 3D-printed masks aim to give kids with breathing problems a better night's sleep

NCT ID NCT07391150

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests custom-made 3D-printed masks for children who use a breathing machine (NIV) at night. Many kids struggle with standard masks that leak, cause sores, or don't fit properly. The new masks are designed from a 3D scan of each child's face to improve comfort and fit. About 195 children aged 1 month to 16 years will try the custom mask and compare it to their current one.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
custom 3D-printed NIV mask and headgear
What this could lead to
If it works, this could provide a comfortable, well-fitting mask for children who currently have no good options, reducing pressure sores and sleep disruption.
What could go wrong
This is a small pilot study, not a large trial. The custom masks may not fit better than standard ones, and the manufacturing process needs further development.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sheffield Children's Hospital, Sheffield, UK

    Sheffield, S6 5AW, United Kingdom

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