A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/11/2018 |
| Start Date: | March 14, 2017 |
| End Date: | April 2021 |
Non-invasive ventilation (NIV) is an important therapy for patients with a number of
neurological diseases. Specifically, NIV has been shown to be an effective treatment for
people with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), which is
a fatal, non-curable, progressive disease of the motor neurons. However, due to changes in
facial structure associated with the disease, many ALS patients find that traditional NIV
masks don't fit well. In this study, investigators will perform a feasibility study on NIV
mask interfaces which are custom designed for each ALS patient and then manufactured via 3D
printing.
neurological diseases. Specifically, NIV has been shown to be an effective treatment for
people with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), which is
a fatal, non-curable, progressive disease of the motor neurons. However, due to changes in
facial structure associated with the disease, many ALS patients find that traditional NIV
masks don't fit well. In this study, investigators will perform a feasibility study on NIV
mask interfaces which are custom designed for each ALS patient and then manufactured via 3D
printing.
Non-invasive ventilation (NIV) is an important therapy for patients with a number of
neurological diseases. Specifically, for amyotrophic lateral sclerosis (ALS)--a fatal,
non-curable, progressive disease of the motor neurons--NIV represents one of the most
effective treatments with a survival benefit of greater than 1 year. Despite this survival
advantage, and the corresponding improvement in Quality of Life (QoL), compliance with NIV
can be poor. Factors contributing to poor compliance to NIV include bulbar onset disease and
mask leaks. In addition to reduced adherence to therapy, elevated mask leaks can compromise
the pressure adjustment algorithm in average volume assured pressure support (AVAPS)
ventilation, a commonly used mode of bilevel (positive airway pressure) PAP therapy in ALS.
In an effort to increase NIV compliance in subjects with neurological conditions, and
specifically ALS, investigators hypothesize that a better fit achieved through 3D printed NIV
mask interfaces may improve utilization by decreasing mask leaks, decreasing the required
delivery pressures and improving compliance with therapy. Investigators therefore propose a
feasibility study to investigate the use of 3D printing to manufacture customized NIV mask
interfaces for subjects with ALS who encounter difficulty using NIV because of poorly fitting
mask interfaces despite exhausting available commercial mask options.
neurological diseases. Specifically, for amyotrophic lateral sclerosis (ALS)--a fatal,
non-curable, progressive disease of the motor neurons--NIV represents one of the most
effective treatments with a survival benefit of greater than 1 year. Despite this survival
advantage, and the corresponding improvement in Quality of Life (QoL), compliance with NIV
can be poor. Factors contributing to poor compliance to NIV include bulbar onset disease and
mask leaks. In addition to reduced adherence to therapy, elevated mask leaks can compromise
the pressure adjustment algorithm in average volume assured pressure support (AVAPS)
ventilation, a commonly used mode of bilevel (positive airway pressure) PAP therapy in ALS.
In an effort to increase NIV compliance in subjects with neurological conditions, and
specifically ALS, investigators hypothesize that a better fit achieved through 3D printed NIV
mask interfaces may improve utilization by decreasing mask leaks, decreasing the required
delivery pressures and improving compliance with therapy. Investigators therefore propose a
feasibility study to investigate the use of 3D printing to manufacture customized NIV mask
interfaces for subjects with ALS who encounter difficulty using NIV because of poorly fitting
mask interfaces despite exhausting available commercial mask options.
Inclusion Criteria:
1. Age greater than 18
2. Ability to communicate in English
3. Diagnosis of ALS
4. Subject followed in the ALS Clinic at University of Michigan
5. Current use of NIV.
6. Problematic mask leak defined as one of the following:
A. A clinical complaint of mask leak impeding use of PAP AND PAP use <6 hours per
night AND/OR B. Average percentage of the night in large leak on download of >10%
(AVAPS)
7. At least 1 month of NIV use
Exclusion Criteria:
1. Subjects successfully using a commercially available mask without objective or
subjective leak with good compliance (average use >6 hours per night)
2. Silicone allergy
We found this trial at
1
site
Click here to add this to my saved trials
