Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Francesca Gowing
+44 (0)207 317 7544
francesca.gowing@nhs.net


Prof Silvia Schievano
+44 (0)2076792000
s.schievano@ucl.ac.uk


Ms Stephanie Mansell
+44 (0)2074726623
stephanie.mansell.21@ucl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Investigating customised positive airway pressure therapy masks versus usual care in the treatment of patients with sleep-disordered breathing
Back

Investigating customised positive airway pressure therapy masks versus usual care in the treatment of patients with sleep-disordered breathing

Not Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Respiratory disorders

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In the UK alone, there are 1.6 million people who have problems with their breathing during sleep. The best treatment is a breathing machine, which is attached via a tube with a tight-fitting mask to the patient face. However, people have different facial shapes, and these off-the-shelf masks sometimes leak air or are uncomfortable. This research will assess whether personalised face masks are better than off-the-shelf masks.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

16 Jan 2023 31 May 2024

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39542493/ (added 15/11/2024)2025 Other publications in https://pubmed.ncbi.nlm.nih.gov/40335145/ Lived experiences of patients using positive airway pressure (PAP) therapy: a nested phenomenological study within the 3DPiPPIn randomised controlled trial (added 08/05/2025)

People who are under the care of the Royal Free London NHS Foundation Trust’s sleep and ventilation service and who need treatment for their sleep-disordered breathing with PAP therapy will be asked to test the customised masks. The research will look at how the customised masks compare to commercially available “off the shelf” masks. It will measure how the two masks affect how well the breathing machines treat breathing problems during sleep.
Further tests will see if there is a difference in the following:
1. How well the mask fits
2. How much do patients use their breathing machine
3. How often do people get skin sores
4. People’s wellbeing
5. Feedback on the comfort of the masks.

This is a randomised controlled trial, which means there will be two groups of patients. One group will be issued with an off-the-shelf mask and one group will be issued with a customised mask. A computer will randomly decide which group each patient will be in. Neither the participant, the research team nor anyone else involved in patient care can decide. If participants decide to take part, each will be asked to complete a consent form and if partaking will be informed when the appointments are. Appointments will be made on a day and time that is convenient for everyone who wants to take part. Before being invited to test the masks, the masks will be tested on small scale in 10 healthy people and 10 people with sleep-disordered breathing. Taking part in this study will involve attending three to four sessions with a member of the research team.

The information below shows what is involved at each visit.
Visit number 1
Off-the-shelf mask group:
We will complete a physical assessment of you
You will be given your PAP machine (CPAP, NIV) and an off-the-shelf mask
We will ask you to complete some questionnaires
A scan of your face will be collected using a handheld scanner
Customised mask group:
A scan of your face will be collected using a handheld scanner
We will complete a physical assessment of you
We will ask you to complete some questionnaires

Visit number 2, 3 months after your first visit
Off-the-shelf mask group:
We will ask you to complete some questionnaires
We will ask you to complete a two-night sleep study
We will complete a physical assessment of you
We will download some information from your PAP machine
Customised mask group:
As soon as possible after your first visit
You will be given your PAP therapy device (CPAP, NIV) and customised mask

Visit number 3, 6 months after your first visit
Off-the-shelf mask group:
We will ask you to complete some questionnaires
We will ask you to complete a two-night sleep study
We will complete a physical assessment of you
We will download some information from your PAP machine
Customised mask group:
3 months after your first visit
We will ask you to complete some questionnaires
We will ask you to complete a two-night sleep study
We will complete a physical assessment of you
We will download some information from your PAP machine

Visit number 4, 6 months after your first visit
There are no actions for the off-the-shelf mask group
Customised mask group:
We will ask you to complete some questionnaires
We will ask you to complete a two-night sleep study
We will complete a physical assessment of you
We will download some information from your PAP machine
We will issue you with an off-the-shelf mask for ongoing treatment

The visit when patients are issued with a PAP machine (visit 1 or 2) will last a maximum of 2 hours. Visits after that will last a maximum of an hour and a half. It may be possible for some of these visits to be conducted via a video platform. If support is required in between the visits, patients will be able to contact the team via phone and email. Patients will be in the study for 6 months in total. The customised mask will have to be returned at the last appointment because the customised masks have not gone through the necessary government and regulatory approvals for long-term use.


Adults with sleep-disordered breathing with an apnoea hypopnea index (AHI) of more than 15 events/hour who need PAP therapy and adult patients who have never had PAP therapy.

You can take part if:



You may not be able to take part if:


Randomised controlled trial: 1. AHI < 152. Excessive facial hair which they are unwilling to shave3. Age < 18years4. Existing facial pressure ulcers5. Unable to provide informed consent6. Known allergy to silicone7. Keloid scarring8. Previous domiciliary PAP therapy

Nested Qualitative studyPatients who are unable to provide informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Free Hospital
    Pond Street
    London
    NW3 2QG

By participating in the study patients will have additional monitoring and extra tests to check their condition. It is hoped that this new way of creating masks will help people to find it easier to wear their masks. It might reduce the side effects people experience from the mask. There is a possibility in the long term that it could reduce costs and waste to the healthcare system. Taking part in the study will take up some time. There is a small risk that people could develop a skin reaction to the materials used in both the off-the-shelf masks and the customised mask. The off-the-shelf masks are made from silicon with a low reported incidence of skin reactions. The customised masks will contain silicon, with a low reported incidence of skin reactions in other products. The customised masks will be based on polyacrylate and be cured to avoid irritation.

Ms Francesca Gowing
+44 (0)207 317 7544
francesca.gowing@nhs.net


Ms Stephanie Mansell
+44 (0)2074726623
stephanie.mansell.21@ucl.ac.uk


Prof Silvia Schievano
+44 (0)2076792000
s.schievano@ucl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University College London and funded by National Institute for Health and Care Research.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN74082423

Or CPMS 54299

Last updated 08 May 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top