Fit Achieved through Contour Engineering to Improve Tolerance -FACE-IT
Research type
Research Study
Full title
Fit Achieved through Contour Engineering to Improve Tolerance (FACE-IT)
IRAS ID
199725
Contact name
Peter Dorrington
Contact email
Sponsor organisation
Papworth Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
Obstructive Sleep Apnoea Syndrome (OSAS) affects 3-7% of men and 2-5% of women in the UK. It is the repetitive narrowing/closure of the upper airway during sleep, resulting in pauses in breathing, causing oxygen levels to drop and brief awakenings. Left untreated it causes excessive daytime sleepiness and consequences such as increases in road traffic accidents; it is also associated with cardiovascular disease. Moderate/severe OSAS is most commonly treated with Continuous Positive Airway Pressure (CPAP), which provides a stream of pressurised air via a face mask to keep the upper airway open in sleep. However, CPAP effectiveness can be limited by intolerance and poor compliance. With good management up to 80% of patients tolerate CPAP, thereby reducing daytime sleepiness, leading to a significant improvement in quality of life. However, a significant minority cannot tolerate CPAP well enough to achieve benefit from the treatment.
A promising avenue for the improved treatment for OSAS sufferers is to increase mask compliance through improved fit.
In a previous service evaluation five users had their faces scanned in one relaxed pose. Using this unmodified data 5 custom fitting masks will be created for evaluation during visit 1. During this visit, users will also have their faces scanned in four typical sleep positions. Data will then be used to create an averaged profile, by aligning multiple scans of the same patient in different poses. A second set of masks with a ‘harmonised’ profile will be made for evaluation in visit 2. User assessments before and after mask usage will take place to understand how a custom design compares with a harmonised design, and subsequently whether 3Dtechnology produces improved masks for these patients.
Findings will be used to develop a larger scale NIHR funded trial of masks crucial for ensuring long-term compliance and improved outcomes for OSAS.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0226
Date of REC Opinion
9 Jun 2016
REC opinion
Favourable Opinion