3D digital manufacturing method to create custom APAP mask cushions
Research type
Research Study
Full title
Investigating the use of 3D scanning and printing technologies for the development of respiratory products for the healthcare industry
IRAS ID
279439
Contact name
Keir Lewis
Contact email
Sponsor organisation
Hywel Dda Health Board
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Obstructive Sleep Apnoea (OSA) is a collapse of the upper airway during sleep, causing snoring and stopping of breathing followed by arousal to restore breathing. A full collapse of the airway is known as an apnoea and a partial collapse is known as a hypopnoea. The severity of OSA is measured by the number of these events per hour known as the Apnoea Hypopnoea Index (AHI). A mild case has 5-14 events, moderate 15 – 29 events, and severe is over 30 events per hour. The disrupted sleep causes the hallmark symptoms of daytime sleepiness. Low oxygen levels and stress responses during sleep can cause high blood pressure, heart rhythm problems, worsen diabetes, chance of having a stroke and causes road traffic accidents.
Automatic Positive Airway Pressure (APAP) is the gold standard treatment for OSA; air pressure is applied to the upper airway through a nose or nose and mouth mask during sleep. APAP has been shown to lessen symptoms immediately, reduce associated health risks and saves the NHS over £45 million/year.
Despite improved quality of life and reduced health risks, around 20-30% of patients do not use APAP appropriately, with over half (65%) referring to mask problems. Further analysis of negative side-effects (NSE) associated specifically with the mask, include mask leaks, discomfort due to ill-fit, skin irritation, feeling claustrophobic, and mask dislodgement during sleep, causing arousal to reapply the mask.
Digital manufacturing methods (DMM) using 3-Dimensional (3D) scanning and 3D printing technologies have been developed to create custom mask cushions to resolve the NSE. The current research has shown improvement in fit, comfort and usability, however, the data only captures the 3D surface of the face and does not take into consideration material properties of face.
We propose a novel DMM to create custom cushion using 3D surface and material property face data.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0239
Date of REC Opinion
19 Nov 2020
REC opinion
Favourable Opinion