3DPiPPIn 2
Research type
Research Study
Full title
The clinical impact of customised Positive Airway Pressure (PAP) therapy interfaces vs usual care in the treatment of patients with sleep disordered breathing
IRAS ID
275073
Contact name
Silvia Schievano
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN74082423
Clinicaltrials.gov Identifier
UCL Data Protection Registration Number, Z6364106 2022 07 146
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
Purpose
In the UK alone, there are 1.6million people who have problems with their breathing during sleep. The best treatment is a breathing machine, which is attached via a tube with a tight-fitting mask to the patient face.
However, people have different facial shapes, and these off-the-shelf masks sometime leak air or are uncomfortable. This research will assess whether personalised face masks are better than off-the-shelf masks.Why is this study needed?
We are currently undertaking initial research using facial scanning and 3D printing to make personalised masks; the proposed study is to test this concept further. The process uses a handheld scanner to take a 3D scan of the person face. Computer software uses this scan to build a cast which is 3D printed. Medical grade silicon is
injected into the cast to make a mask, attached to a frame, which fits the person facial shape perfectly. We think these personalised masks will have fewer side effects and help more people benefit from treatment.What will be done in this study?
The study will have two groups of patients: one group will be given “off-the-shelf masks and the other group a personalised mask. Patients will be randomly allocated to one of the two groups, by a computer. We will study people for 6 months, with four to five visits during the study. We will measure how the two masks affect how well the breathing machines treat the breathing problems during sleep.
We will also see if there is a difference in:
how well the mask fits
how much patients use their breathing machine
how often people get skin sores
people’s wellbeing
feedback on the comfort of the masks.Some of the people will take part in an interview about their experiences using masks for their breathing machines.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0405
Date of REC Opinion
1 Nov 2022
REC opinion
Favourable Opinion