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

NCT03519880 | Terminated

• 1 other identifier: HUM00112433
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis, non-invasive ventilation, mask, custom, 3D-printing

Outcome Measures

Primary Outcomes (3)

• Average number of hours the custom NIV mask interface is used per night

  Average number of hours the custom NIV mask interface is used per night

  1 month

• Leak parameters from device

  Average minutes in large leak or leak measured from the device in liters per minute and averaged over the month

  1 month

• Tidal volume measurements

  (average measured tidal volume/average set tidal volume)\*100%

  1 month

Secondary Outcomes (1)

• Interviews with subjects regarding their experience with the custom mask Qualitative assessment of custom NIV mask efficacy

  1 month

Other Outcomes (6)

• ALS Depression Inventory-12 (ADI-12)

  1 month

• ALS Functional Rating Scale, Revised (ALSFRS-R)

  1 month

• ALS Specific Quality of Life-20 (ALSSQOL20)

  1 month

Study Arms (1)

Custom Mask Interface

EXPERIMENTAL

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.

Device: Custom Mask Interface

Interventions

Custom Mask Interface DEVICE

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

Custom Mask Interface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan: lead
• ALS Association: collaborator

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen A Goutman, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: All trial enrollees will receive the custom-designed 3D printed non-invasive ventilation mask interface.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 9, 2018
• Study Start: March 14, 2017
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)