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

NCT ID: NCT03519880

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2020-03-14

Brief Summary

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.

Detailed Description

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Custom Mask Interface

Patients use a custom mask interface for one month with an option to use for a year if it performs better than a commercial mask.

Group Type: EXPERIMENTAL

Custom Mask Interface

Intervention Type: DEVICE

Subjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface.

Interventions

Custom Mask Interface

Subjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALS Association

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Stephen Goutman

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen A Goutman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Medicine

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00112433

Identifier Type: -

Identifier Source: org_study_id