Clinical trial NCT03519880: A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
Official title: A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis, non-invasive ventilation, mask, custom, 3D-printing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2018-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All trial enrollees will receive the custom-designed 3D printed non-invasive ventilation mask interface.
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Average number of hours the custom NIV mask interface is used per night
timeFrame: 1 month
measure: Leak parameters from device
timeFrame: 1 month
measure: Tidal volume measurements
timeFrame: 1 month
Secondary outcomes:
measure: Interviews with subjects regarding their experience with the custom mask Qualitative assessment of custom NIV mask efficacy
timeFrame: 1 month
Other outcomes:
measure: ALS Depression Inventory-12 (ADI-12)
timeFrame: 1 month
measure: ALS Functional Rating Scale, Revised (ALSFRS-R)
timeFrame: 1 month
measure: ALS Specific Quality of Life-20 (ALSSQOL20)
timeFrame: 1 month
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 1 month
measure: PROMIS Neuro-Quality of Life Fatigue Scale
timeFrame: 1 month
measure: PROMIS Neuro-Quality of Life Sleep Disturbance Scale
timeFrame: 1 month
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephen A Goutman, MD
role: PRINCIPAL_INVESTIGATOR
References: