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

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

Quick Info:

Status:
Enrolling by invitation
Estimated Enrollment:
40
Phase:
N/A
Treatment Type:
Device: Custom Mask Interface
Trial Type:
Single Group Assignment, No masking, open Label
Sponsor:
University of Michigan
Primary Investigator:
Contact Information:
    Contact information unknown.

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
Yes
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
Yes
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

5/14/2018Trial added

Locations:

Ann Arbor, Michigan,

Other Information:

Purpose: 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.
Eligibility: 18 Years and older, all genders, not accepting healthy volunteers
Details: 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.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 5/9/2018
ClinicalTrials.gov ID: NCT03519880
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov