Title: The clinical impact of customised Positive Airway Pressure (PAP) therapy interfaces vs usual care in the treatment of patients with sleep disordered breathing
Funder: Department of Health and Social Care

Abstract: Background: Sleep disordered breathing (SDB) affects 1.6million people in the UK. The recognised treatment is positive airway pressure (PAP) therapy, delivered via an interface (mask) attached to the patient's face. PAP therapy improves morbidity, mortality and quality of life (QoL), but treatment effectiveness depends upon interface fit. Side effects associated with interfaces include pressure ulcers, skin reactions and interface leak. 3D printing is an innovative technology, which can be used to produce customised interfaces.Research title:The use of customised PAP therapy interfaces in the treatment of patients with sleep disordered breathingAims:The primary aim is to assess the impact of customised interfaces versus conventional interfaces on residual Apnoea Hypopnea Index (AHI) at 6 months.Secondary objectives: To assess clinical impact of customised interfaces on mask leak, concordance with PAP treatment, pressure ulcer incidence, health related QoL and symptoms. To explore experiences of patients using PAP interfaces. Methods:Trial Design: Randomised control trial via block randomisation, minimised by age >65 and ethnicity, using computerised random number generator.Participants: Patients will be recruited from those with sleep disordered breathing under the care of Royal Free London NHS Foundation Trust.Interventions: Patients new to therapy will be randomised to customised interface or conventional interface, with the duration of the study being 6 months. A nested qualitative study will recruit patients from both arms. Data will be collected using semi-structured interviews within an approach of interpretative phenomenology to explore the patients' lived experience.Sample size: A sample size of 160 (80 per group) is required for a power of 0.8 with a significance of 0.05, accounting for a 20% dropout rate. The nested qualitative study will aim to recruit 30 participants. Purposive sampling will ensure participants represent the demographics of the population.AnalysisDescriptive statistics will report the demographics of the patients. The primary and secondary outcomes will be compared using linear regression adjusted for baseline.Qualitative: A reflective thematic analysis using Braun and Clarke's six phase analysisTimelines for deliveryPrior to month 1-3: Submit approvals and set up studyMonth 4: Recruitment commencesMonth 18: MPhil/PhD Upgrade, associated write up and analysisMonth 24: Recruitment completeMonth 30: 6 month follow up completeMonth 31: AnalysisMonth 30: Write up and disseminationAnticipated impact and disseminationResults will be disseminated to healthcare professionals at conferences and through open access peer reviewed journals. Dissemination to patients will be through patient conferences and newsletters. A webpage will be maintained throughout the study, including infographics and animations. Social media will be utilised to disseminate results. Appropriate healthcare awards will be considered as a channel for sharing the research.

Lay abstract: PurposeIn the UK alone, there are 1.6million 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 sometime leak air or are uncomfortable. This research will assess whether personalised face masks are better than off-the-shelf masks.Why is this study needed? We know how well the breathing machine works depends upon the fit of the mask. We know there are side effects from using off-the-shelf masks, such as air leaking and skin damage, and these side effects make it difficult for patients to use their breathing machine.We are currently undertaking initial research using facial scanning and 3D printing to make personalised masks; the proposed study is to test this concept further. The process uses a handheld scanner to take a 3D scan of the person face. Computer software uses this scan to build a cast which is 3D printed. Medical grade silicon is injected into the cast to make a mask, attached to a frame, which fits the person facial shape perfectly. We think these personalised masks will have fewer side effects and help more people benefit from treatment.What will be done in this study?We will conduct a study looking at how personalised masks work compared to off-the-shelf masks. The study will have two groups of patients: one group will be given 'off-the-shelf masks and the other group a personalised mask. Patients will be randomly allocated to one of the two groups, by a computer. We will study people for 6 months, with four to five visits during the study. Participants to the Patient and Public Involvement workshops have made it clear they would wish to keep their personalised masks at the end of the study. We will measure how the two masks affect how well the breathing machines treat the breathing problems during sleep.We will also see if there is a difference in: how well the mask fits how much patients use their breathing machine how often people get skin sores people's wellbeing feedback on the comfort of the masks. Some of the people will take part in an interview about their experiences using masks for their breathing machines.How will patients be involved?We have asked some patients to look at the study design and we have made some changes as a result. We have asked members of the public to look at this summary. We will ask patients to help us create all the documents associated with the study. To ensure the research is run appropriately, we will have a trial management committee which will include a patient. We have also asked patients how they would like us to tell them about the study results and have asked patients to help us share these results.Telling people the results of the studyWe will tell other healthcare professionals, including GPs, about the study results at conferences and by publishing the results in journals that anyone can access. We will tell patients about the results at patient conferences, through newsletters and blogs. There will be a webpage about the study, and information will be provided in ways that are easy to read and understand such as infographics (a visual display of results using pictures) and animations. Social media will be mobilised to tell the public about the study results. We will think about applying to local and national healthcare awards as a way of sharing the research.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY;DISPUTED AETIOLOGY AND OTHER