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3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study — 3DPiPPIn  

Sleep Disordered Breathing Clinical Trial

Official title:
3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study

Clinical Trial Summary

This study is a single site pilot and feasibility study. We propose that 3D printing could be used to create customised masks for patients requiring Positive Airway Pressure (PAP) therapy. We hypothesise that the use of this technology may result inÍž improved compliance with therapy, increased comfort, reduced side effects, increased quality of life and reduced healthcare costs.

Clinical Trial Description

Stage 1: 10 health participants. subjects will be asked to attend for a mask fitting using off the shelf standard mask stock. They will then be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed. Subjects will then attend for 3D printing of a mask. Following the production of the 3D mask, repeat measurements with the 3d mask on PAP therapy will be taken. If all healthy subjects complete the trial without any serious adverse events, then the second phase of the study with patients will commence. Stage 2: Patients with an established diagnosis of sleep disordered breathing with known mask concerns will be recruited from the Royal Free London NHS Foundation Trust (RFL) Sleep and Ventilation Service. Subjects will be asked to attend for a mask fitting using their existing mask standard stock and will be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed. Any side effects will be documented via photographs. The number and cost of previous masks used since starting PAP therapy (breathing machine) will be also be recorded. Patients will then attend for 3D printing of a mask and repeat measurements with the 3D mask on 10 minutes of their usual PAP therapy will be taken. If there are no serious adverse events/reactions during the PAP trial with the 3D printed mask patients will go on to have a one-night trial on PAP therapy as per their normal PAP (breathing machine) regime. If there are no adverse events or reactions during the one-night trial then patients will proceed to a further four nights of trial with the 3D printed mask. A comparison of scores will be made with standard and 3D printed masks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04179123
Study type Interventional
Source University College, London
Contact Stephaie Mansell
Phone 02077940500
Email rf-tr.3dpippin@nhs.net
Status Recruiting
Phase N/A
Start date March 15, 2020
Completion date September 30, 2023
View Details
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