ArticleBMJ open2024
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.
Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07406620 (Entropy-Based Assessment of Physiological Signals in Obstructive Sleep Apnoea Patients Pre and Post Continuous Positive Airway Pressure Therapy), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Entropy-Based Assessment of Physiological Signals in Obstructive Sleep Apnoea Patients Pre and Post Continuous Positive Airway Pressure Therapy: A Secondary Analysis of 3DPiPPIn Trial Data
Who cites it
2 citing papers in PubMed.
- Residual Apnoea-Hypopnoea Index Measurement from Positive Airway Pressure Devices versus Home Polygraphy: A Method Comparison Study Using Real-World Data.Respiration; international review of thoracic diseases · 2026Article
- Evaluating Patient and Public Involvement and Engagement Activity Within the 3DPiPPIn Trial: A Qualitative Exploration of Contributors' Perspectives on Their Impact.Health expectations : an international journal of public participation in health care and health policy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSleep-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.
aimsThe 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.
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