3D PIPPIN
Research type
Research Study
Full title
3D printing of positive airway pressure (PAP) therapy masks: a single site pilot and feasibility study
IRAS ID
222626
Contact name
Stephanie K Mansell
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2018/05/136 health research, UCL Data Protection Office
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Research Summary
Problems with breathing during sleep (sleep disordered breathing) is a common condition and can be treated using a breathing machine (positive airway pressure (PAP)). Obstructive sleep apnoea (OSA) affects 1-2% of the UK population whilst the incidence of requirement for non-invasive ventilation is thought to be 4.1 per 100,000 population. Studies have shown that use of these breathing machines improves morbidity, mortality and quality of life (QoL). Use of these breathing machines is dependent upon comfort; patients can often find the mask uncomfortable thus limiting their use of their machine. Furthermore, pressure ulcers (skin sores) are a documented side effect of PAP. The development of pressure ulcers further limits patients’ ability to use their machine. In addition to pressure ulcers, patients are known to develop skin reactions. To our knowledge there are only six manufacturers of masks in the UK and the range is limited to “off the shelf” sizes (e.g. small, medium, large) which do not always fit every patient. Additionally, there is a heavy cost burden with each mask costing in the region of £80. Patients often require several mask fittings before a reasonable fit is found. These current products do not take into account different facial shapes due to gender, ethnicity or medical conditions. Thus there are groups of patients whose therapy is detrimentally affected due to mask leak or mask tolerance. Reduced tolerance and effectiveness of treatment can lead to reduced quality of life and potentially impact on morbidity and mortality.
3D printing is an innovative technology which has been used in variety of healthcare settings. This project aims to pilot the feasibility of using 3D printing technology to develop customised masks for patients receiving PAP therapy
Summary of Results
Sleep-disordered breathing (SDB) is a group of conditions that affects breathing during sleep. Whilst asleep the airways become narrowed, which results in short pauses in breathing or shallow breathing. Sleep-disordered breathing includes conditions like obstructive sleep apnoea (OSA), which affects many people and can lead to serious health problems. One common treatment is positive airway pressure (PAP) therapy. PAP therapy involves wearing a tight-fitting mask connected to a breathing machine whilst asleep. This allows a flow of air to be pumped into the airways, helping to keep them open and support breathing. However, many patients find the standard masks uncomfortable, making it difficult to use the breathing machine.
Our study explored using 3D printing to create custom-fit PAP therapy masks. We scanned people’s faces using a hand held 3D scanner to make a customised PAP therapy mask. This ensured that each mask was designed to match each person's unique face shape and accommodated their facial features. We wanted to see if these customised masks could improve comfort and reduce issues like air leaks and skin irritation. We recruited 20 participants: 10 healthy individuals and 10 patients. Each participant had their face scanned using a camera on a tablet with specialist software to create a customised mask using 3D printing and medical-grade silicone.
The results showed that the 3D printed custom masks had fewer air leaks and that the breathing machine was more effective in treating the participants. However, there was only a marginal difference in comfort between the customised and off-the-shelf masks, and there were signs that reduced comfort could make it more challenging to use the breathing machine. Additionally, the manufacturing process had a high failure rate, meaning that reliably creating these masks is still challenging. Despite this, the custom masks showed promise in improving mask fit and treatment effectiveness. This research has informed a more extensive and longer duration randomised controlled trial, where the customised masks are tested against the off-the-shelf masks in a more rigorous process.
In conclusion, 3D-printed custom PAP masks could be a valuable tool for treating sleep-disordered breathing. However, further improvements in understanding how we can improve comfort and the manufacturing process are needed.REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1875
Date of REC Opinion
4 Jan 2019
REC opinion
Further Information Favourable Opinion