A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects

Stopped early · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT03519880

Run by

University of Michigan

People needed

5

Starts

2017-03-14

Expected to finish

2020-03-14

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18
• Ability to communicate in English
• Diagnosis of ALS
• Subject followed in the ALS Clinic at University of Michigan
• Current use of NIV.
• 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)
• At least 1 month of NIV use

You may not qualify if…

• Subjects successfully using a commercially available mask without objective or subjective leak with good compliance (average use >6 hours per night)
• Silicone allergy

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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