Investigating customised positive airway pressure therapy masks versus usual care in the treatment of patients with sleep-disordered breathing
| ISRCTN | ISRCTN74082423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74082423 |
| IRAS number | 275073 |
| Secondary identifying numbers | CPMS 54299, IRAS 275073 |
- Submission date
- 07/12/2022
- Registration date
- 10/01/2023
- Last edited
- 08/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
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.
Who can participate?
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.
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
Royal Free London NHS Foundation Trust (UK) and University College London (UK)
When is the study starting and how long is it expected to run for?
July 2021 to May 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) Academy (UK); Grant Codes: NIHR302337
Who is the main contact?
Stephanie Mansell, Stephanie.mansell.21@ucl.ac.uk (UK)
Contact information
Scientific
Clinical Trial co-ordinator (Therapies)
Royal Free London NHS Foundation Trust
Royal Free Hospital
Physiotherapy Department Rheumatology Research Office
Lower Ground Floor Pond Street
London
NW3 2QG
United Kingdom
| Phone | +44 (0)207 317 7544 |
|---|---|
| francesca.gowing@nhs.net |
Principal Investigator
Royal Free Hopsital
Pond Street
London
NW3 2QG
United Kingdom
 ORCID ID |
0000-0002-2806-380X |
|---|---|
| Phone | +44 (0)2074726623 |
| stephanie.mansell.21@ucl.ac.uk |
Scientific
University College London
Level 8
Nurses Home
Cardiac Unit
Great Ormond Street Hospital for Children
Great Ormond Street
London
WCIN 3JH
United Kingdom
| ORCID ID |
0000-0003-2037-5339 |
|---|---|
| Phone | +44 (0)2076792000 |
| s.schievano@ucl.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Nested qualitative study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The clinical impact of customised positive airway pressure (PAP) therapy interfaces versus usual care in the treatment of patients with sleep-disordered breathing |
| Study acronym | 3DPiPPIn 2 |
| Study objectives | Customised interfaces will result in greater improvements in residual apnoea hypopnea index (AHI) compared to conventional interfaces |
| Ethics approval(s) | Approved 02/12/2022, South Central – Hampshire B (Meeting held by video-conference via Zoom; +44 (0)207 104 8088, (0)20 7104 8289, (0)20 7104 8289; hampshireb.rec@hra.nhs.uk), ref: 22/SC/0405 |
| Health condition(s) or problem(s) studied | Respiratory disorders |
| Intervention | The following examinations and investigations (if not already performed as part of routine standard of care) shall be performed for determining eligibility for enrolment into this Investigation: RCT A 3D scan using a hand-held scanner of all participants' faces will be collected. Participants will undergo a physical assessment to collect sociodemographic and anthropometric data and measure the prevalence of pressure ulcers via the European Pressure Ulcer Advisory Panel (EPUAP) score. This will be conducted at baseline, 3 months and 6 months. Participants will complete the following questionnaires at baseline, 3 months and 6 months: Epworth Sleepiness Scale (ESS), Sleepiness-Wakefulness Inability and Fatigue test (SWIFT), S3-non-invasive ventilation (S3NIV) and interface questionnaire. Participants will undergo an initial 10-minute trial of PAP therapy with the customised 3D-printed mask to assess for mask leaks, skin reactions and comfort scores. If there are no serious adverse events/reactions during the PAP trial with the 3-D printed mask, patients will go on to have PAP therapy as per their normal PAP regime. Participants will undergo a two-night cardiorespiratory sleep study at baseline, 3 months and 6 months. Participants on NIV will have a capillary blood gas (CBG) at baseline, 3 and 6 months Data from participants' PAP therapy devices will be downloaded at 3 months and 6 months, Specific data collected will be: Compliance with PAP therapy, measured as hours and percentage of days PAP therapy used >4 hours/night over 28 days, measured prior to 3 months and 6 months in concordance with internationally recognised definitions of compliance. Interface leak, measured as average L/min and percentage of the intentional leak over 7 days Nested Qualitative study Participants recruited for the nested qualitative study will undergo a 1:1 semi-structured interview at a location of the patients choosing. Following their participation in the trial patients will receive ongoing care from the sleep and ventilation team as per standard care. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 3D printing positive pressure interfaces |
| Primary outcome measure | Apnoea hypopnea index (AHI) measured using the limited cardio-respiratory sleep study at 6 months |
| Secondary outcome measures | 1. Apnoea hypopnea index (AHI) measured using the limited cardio-respiratory sleep study at 3 months 2. Interface leak measured using average L/min and percentage of the intentional leak over 7 days from positive airway pressure (PAP) therapy data downloads at 3 and 6 months 3. Residual AHI measured using PAP therapy data downloads for further validation of AHI at 3 and 6 months 4. Incidence of pressure ulcers measured using the European Pressure Ulcer Advisory Panel (EPUAP) score (0 to 4) at 3 and 6 months 5. Compliance with PAP therapy, measured as hours and percentage of days PAP therapy used >4 hours/night over 28 days, measured prior to 3 and 6 months 7. Symptoms measured using the Epworth Sleepiness Score (ESS) and Sleepiness-Wakefulness Inability and Fatigue test (SWIFT) at baseline, and 3 and 6 months. 8. Comfort as measured by the S3-non-invasive ventilation (S3NIV) questionnaire and the interface questionnaire, at baseline, and 3 and 6 months. |
| Overall study start date | 01/07/2021 |
| Completion date | 31/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 160; UK Sample Size: 160 |
| Key inclusion criteria | Randomised controlled trial: 1. Diagnosis of SDB (AHI > = 15) confirmed with a home-based sleep study and requiring PAP therapy 2. Patients naive to domiciliary PAP therapy 3. Age > = 18years Nested Qualitative study: Patients participating in study 1 |
| Key exclusion criteria | Randomised controlled trial: 1. AHI < 15 2. Excessive facial hair which they are unwilling to shave 3. Age < 18years 4. Existing facial pressure ulcers 5. Unable to provide informed consent 6. Known allergy to silicone 7. Keloid scarring 8. Previous domiciliary PAP therapy Nested Qualitative study Patients who are unable to provide informed consent |
| Date of first enrolment | 16/01/2023 |
| Date of final enrolment | 31/05/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW3 2QG
United Kingdom
Sponsor information
Hospital/treatment centre
C/o: Pushpsen Joshi
4th Floor
West 250 Euston Road
London
NW1 2PG
England
United Kingdom
| Phone | +44 (0)20 3447 9928 |
|---|---|
| uclh.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to maintaining the anonymity of patients as the study team is unable to anonymise the date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 14/11/2024 | 15/11/2024 | Yes | No | |
| Other publications | Lived experiences of patients using positive airway pressure (PAP) therapy: a nested phenomenological study within the 3DPiPPIn randomised controlled trial | 06/05/2025 | 08/05/2025 | Yes | No |
Editorial Notes
08/05/2025: Publication reference added.
15/11/2024: Publication reference added.
01/02/2023: Internal review.
07/12/2022: Trial's existence confirmed by the NIHR.
