Clinical impact of customised positive airway pressure (PAP) therapy interfaces versus usual care in the treatment of patients with sleep-disordered breathing (3DPiPPIn): a randomised controlled trial protocol.

Introduction: Sleep-disordered breathing affects 1.6 million people in the UK. The recognised treatment is positive airway pressure (PAP) therapy, delivered via a generic conventional interface (mask). PAP therapy improves morbidity, mortality and quality of life, but treatment effectiveness depends on interface fit and tolerance. Interface side effects include pressure ulcers, skin reactions and interface leak. Three-dimensional (3D) printing is an innovative technology that can produce customised interfaces.

Aims: The primary aim is to assess the impact of customised versus conventional interfaces on residual Apnoea Hypopnea Index at 6 months.

Methods And Analysis: This is a randomised control trial via block randomisation, minimised by age >65 and ethnicity, using a computerised random number generator. Patients with sleep-disordered breathing under the care of the Royal Free London NHS Foundation Trust will be recruited. Patients new to therapy will be randomised to customised interface or conventional interface for 6 months. A sample size of 160 is required for 80% power with a significance of 5%, accounting for a 20% dropout rate. Descriptive statistics will report demographics. The primary and secondary outcomes will be compared using linear regression adjusted for baseline score.

Ethics And Dissemination: This protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, a study webpage, infographics, animations, social media and healthcare awards.

Isrctn Registration Number: 74082423.