Respiratory InsufficiencyNIV MasksNCT07391150
NIV Mask and Headgear Evaluation
A study testing NIV Mask in people with Respiratory Insufficiency, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- NIV Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's Hospital, Sheffield, UK
Sheffield, S6 5AW
About this study
Official title: Pilot Evaluation of 3D Designed Custom-made Integrated Mask/Headgear For Children Using Non-Invasive Ventilation (The "COMFORT" Study - Customised Masks For Overnight Respiratory Therapy)
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.
Read more
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.
Read the detailed description
Non-invasive ventilation (NIV) is a method of providing artificial respiratory support without placement of a tube in the airway; the air pressure is applied externally through the nose and/or the mouth. NIV was developed in the 1980s to support breathing in children with nocturnal hypoventilation due to neuromuscular weakness. In recent years the use of NIV has been offered to an extended group of patients with acute and chronic respiratory failure.
The aims of NIV are to improve gas exchange and to improve respiratory symptoms. Without ventilation, these patients will suffer chronic hypoxia resulting in pulmonary hypertension, cor pulmonale and premature death. NIV is effective in correcting nocturnal hypoventilation and in alleviating the associated symptoms. There is evidence that the use of NIV improves the quality of life in children with neuromuscular disorders and the life expectancy with those who decline NIV being more likely to die of respiratory failure within 2 years (6-12). NIV has been shown to reduce both hospital admissions (2-4 per year pre-NIV and 1 per year post-NIV) and days spent in hospital (40-50 per year pre-NIV and 10 per year post-NIV). Further work to look at this is underway within our group.
The biggest challenge with NIV treatment is enabling the child to tolerate the interface; the biggest cause of failure of NIV is the inability to fit a comfortable mask. Air leaks around the mask due to poor fit are a common reason for NIV to be ineffective and to be poorly tolerated. Pressure from an NIV mask on the growing face can result in under-development of the maxilla, leading to mid-face flattening and mal-occlusion of the teeth after as little as 4 weeks. Breakdown of the skin and pressure sores, usually on the bridge of the nose or forehead can occur when using mask ventilation. Prevention is better than cure and can be achieved if a suitably fitting mask is available.
NIV masks are available commercially for standard-size adults and children, but a good fit can be difficult to obtain in children with facial dysmorphic syndromes and other underlying co-morbidities. Custom-made masks are associated with a lower incidence of skin injury but are not available in most UK centres. The COMFORT project has developed a prototype custom made mask as well as a modular headgear prototype using 3D scanning and printing technology. Further work is taking place to inform the optimal 3D scanning technique and a software algorithm to automate the design process. This pilot clinical study will gain data in order to inform a multicentre clinical trial.
- Conditions
- Respiratory Insufficiency
- Being tested
- NIV Mask
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV MaskDevice
NIV Mask (custom)
| Study group | Role | What they receive |
|---|---|---|
| NIV Masks | Experimental | Not described Receives: Device: NIV Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort
Measured using a investigator devised qualitative diary card
Measured: Until study completion - typically 6 months
Patient sleep quality
Measured using a investigator devised qualitative diary card
Measured: Until study completion - typically 6 months
Patient skin marking
Measured using a investigator devised qualitative diary card
Measured: Until study completion - typically 6 months
In-patient and home sleep studies
Measured using SpO2 and actigraphy monitoring
Measured: Until study completion - typically 6 months
Mask leak data
Measured using ventilator SD card data
Measured: Until study completion - typically 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start23 Feb 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University, University of Nottingham, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391150
- Sponsor's protocol ID
- SCH-2757
- Acronym
- NIV Masks
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of 3D Designed Custom-made Integrated Mask/Headgear For Children Using Non-Invasive Ventilation (The "COMFORT" Study - Customised Masks For Overnight Respiratory Therapy)
- ClinicalTrials.gov ID
- NCT07391150
- Acronym / sponsor ID
- NIV Masks / SCH-2757
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University, University of Nottingham, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-invasive ventilation (NIV) is a method of providing artificial respiratory support without placement of a tube in the airway; the air pressure is applied externally through the nose and/or the mouth. NIV was developed in the 1980s to support breathing in children with nocturnal hypoventilation due to neuromuscular weakness. In recent years the use of NIV has been offered to an extended group of patients with acute and chronic respiratory failure.
The aims of NIV are to improve gas exchange and to improve respiratory symptoms. Without ventilation, these patients will suffer chronic hypoxia resulting in pulmonary hypertension, cor pulmonale and premature death. NIV is effective in correcting nocturnal hypoventilation and in alleviating the associated symptoms. There is evidence that the use of NIV improves the quality of life in children with neuromuscular disorders and the life expectancy with those who decline NIV being more likely to die of respiratory failure within 2 years (6-12). NIV has been shown to reduce both hospital admissions (2-4 per year pre-NIV and 1 per year post-NIV) and days spent in hospital (40-50 per year pre-NIV and 10 per year post-NIV). Further work to look at this is underway within our group.
The biggest challenge with NIV treatment is enabling the child to tolerate the interface; the biggest cause of failure of NIV is the inability to fit a comfortable mask. Air leaks around the mask due to poor fit are a common reason for NIV to be ineffective and to be poorly tolerated. Pressure from an NIV mask on the growing face can result in under-development of the maxilla, leading to mid-face flattening and mal-occlusion of the teeth after as little as 4 weeks. Breakdown of the skin and pressure sores, usually on the bridge of the nose or forehead can occur when using mask ventilation. Prevention is better than cure and can be achieved if a suitably fitting mask is available.
NIV masks are available commercially for standard-size adults and children, but a good fit can be difficult to obtain in children with facial dysmorphic syndromes and other underlying co-morbidities. Custom-made masks are associated with a lower incidence of skin injury but are not available in most UK centres. The COMFORT project has developed a prototype custom made mask as well as a modular headgear prototype using 3D scanning and printing technology. Further work is taking place to inform the optimal 3D scanning technique and a software algorithm to automate the design process. This pilot clinical study will gain data in order to inform a multicentre clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIV Masks | Experimental | Device: NIV Mask |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV MaskNIV Mask (custom) | Device | NIV Masks |
Primary outcome
Patient comfort
Time frame: Until study completion - typically 6 months
Measured using a investigator devised qualitative diary card
Patient sleep quality
Time frame: Until study completion - typically 6 months
Measured using a investigator devised qualitative diary card
Patient skin marking
Time frame: Until study completion - typically 6 months
Measured using a investigator devised qualitative diary card
In-patient and home sleep studies
Time frame: Until study completion - typically 6 months
Measured using SpO2 and actigraphy monitoring
Mask leak data
Time frame: Until study completion - typically 6 months
Measured using ventilator SD card data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
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Recruiting
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV Mask in people with Respiratory Insufficiency, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort (time frame: Until study completion - typically 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.