NIV Mask and Headgear Evaluation

NCT07391150 | Active Not Recruiting

• 1 other identifier: SCH-2757
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive ventilation (NIV) is the delivery of breathing support via a facemask. It is used to treat people whose natural breathing is ineffective. Evidence shows that, when used long-term, it improves both quality of life and life expectancy. Ventilation is delivered in the home through a mask covering the nose or the nose and mouth. A good fit between the mask and the patient's face is essential to deliver the treatment effectively. Mass-produced masks are available for the adult market but in children it is often difficult to find a mask that provides an adequate fit. A particularly disadvantaged group is children with facial deformities or facial asymmetry. In these groups NIV may not be possible due to unavailability of an adequate mask. Currently the options for these groups of children are to ventilate invasively via a breathing tube (tracheostomy) which can lead to serious complications and costly care-packages or to abandon ventilation, eventually leading to respiratory failure and premature death. Persevering with an inadequately fitting mask leads to pressure sores, impairment of facial bone growth and significant disturbance to the sleep of the child and family due to noise from air leakage from the mask and alarms from the ventilator. These problems lead to an increased burden on nursing and hospital resources as well as harm and suffering to patients. The COMFORT study was funded by the NIHR in 2015 to develop novel mask-face interfaces to optimise mask fit to the needs of individual patients using 3D assessment and manufacturing technologies. Since then, we have developed a mask prototype and a modular headgear prototype that straps the mask onto the face. We have already demonstrated that our proposed method is more effective than a standard mass-produced mask/headgear in the laboratory setting with adult volunteers. In the first part of this project, we will carry out a proof-of-concept study to test the prototype mask/headgear system with children and young people that currently use NIV but have a poorly-fitting mask. We will compare our new system with their current mask by asking them to rate them in terms of comfort and fit as well as measuring the effectiveness of their ventilation. In the second part, we will work with Imperial University, who have developed software to automate and speed up the manufacturing process. We will scan 120 children to help develop the software to be suitable for children and then repeat the proof-of-concept study with a mask manufactured using the automated process. Following these studies we will apply for funding to carry out a multicentre UK-wide clinical trial.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (5)

• Patient comfort

  Measured using a investigator devised qualitative diary card

  Until study completion - typically 6 months

• Patient sleep quality

  Measured using a investigator devised qualitative diary card

  Until study completion - typically 6 months

• Patient skin marking

  Measured using a investigator devised qualitative diary card

  Until study completion - typically 6 months

• In-patient and home sleep studies

  Measured using SpO2 and actigraphy monitoring

  Until study completion - typically 6 months

• Mask leak data

  Measured using ventilator SD card data

  Until study completion - typically 6 months

Study Arms (1)

NIV Masks

EXPERIMENTAL

Device: NIV Mask

Interventions

NIV Mask DEVICE

NIV Mask (custom)

NIV Masks

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients requiring NIV as part of usual clinical care at SCH
• Age 1 month to 16 years.
• Difficulties with current NIV interface
• Only patients that are using NIV for breathing support will be included, ie those with hypoventilation and obstructive sleep apnoea, where the ventilator supports the patient's own breathing.

You may not qualify if:

• Families who do not understand written or verbal English where no interpreter is available.
• Children who do not attend with their parent /legal guardian and so are therefore unable to give informed consent.
• Patients deemed too unwell, or unsuitable, by the clinical team
• Patients with adequately functioning NIV interface.
• Patients requiring supplementary medical gases, eg oxygen.
• Patients requiring NIV for rescue breaths will be excluded, ie those with disorders of respiratory control where the ventilator is delivering breaths where the patient has stopped breathing.

Sponsors & Collaborators

• University of Nottingham: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Sheffield Children's NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator

Study Sites (1)

Sheffield Children's Hospital, Sheffield, UK

Sheffield, S6 5AW, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: February 5, 2026
• Study Start: February 23, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)