Utility of 3D printed masks for improving compliance and efficacy of non-invasive ventilation in subjects with amyotrophic lateral sclerosis: A pilot feasibility study
Non-invasive ventilation (NIV) is the most effective treatment for amyotrophic lateral sclerosis (ALS) extending life by over a year while also improving quality of life, yet, poorly fitting masks for NIV can limit patient’s use of this device. Our long-term goal is to develop an improved patient interface for NIV in order to enhance therapeutic compliance. The overall objective of this application, which is the next step toward attainment of our long-term goal, is to perform a pilot feasibility study of three-dimensional (3D) printed NIV masks in subjects with ALS to evaluate where machine compliance is strengthened. Our central hypothesis is that a customized NIV interface, accounting for the specific facial characteristics of subjects with ALS, specifically, facial weakness. Our hypothesis is based on our clinical recognition that some ALS subjects are unable to tolerate NIV as a result of mask leaks from facial weakness.
The rationale for the proposed research is that a customized interface for NIV in ALS subjects may improve NIV compliance, thereby improving quality of life and survival; further a pilot experience of 3D printed masks for subject with ALS will generate the preliminary data required for a clinical trial. We will test this hypothesis with three specific aims: 1) Determine whether a 3D printed NIV mask can improve device compliance compared to the commercially fitted mask; 2) Evaluate whether the use of a customized NIV mask can improve pulmonary clinical outcomes measures; and 3) Obtain preliminary data for grant to study this methodology in a clinical trial.
To accomplish these aims, a topographical model of the face of the research participant will be generated to fabricate a NIV mask using a 3D printer. The change in NIV machine compliance between the commercially available mask and the custom 3D printed mask will be compared. The approach is innovative, in the applicants opinion, because it represents a substantive departure from the status quo by addressing NIV device tolerance and compliance, an area not currently addressed by evidence-based literature. The approach is significant because it will improve the compliance of the most effective treatment for ALS.