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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03519880
• Other study ID #: HUM00112433
• Status: Terminated
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: March 14, 2020

Study information

• Verified date: April 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Device:
• Custom Mask Interface
Subjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	ALS Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ALS Depression Inventory-12 (ADI-12)	Depression Scale. Scales: For each question, the following is selected: "I fully agree", "I agree", "I don't agree", "I do not agree at all"	1 month
Other	ALS Functional Rating Scale, Revised (ALSFRS-R)	Functional Rating Scale. Scales: Customized for each question, but 4 is the maximum and generally means 'normal', and 0 represents significant impairment.	1 month
Other	ALS Specific Quality of Life-20 (ALSSQOL20)	Quality of Life Scale. Scales: For each question, 1-10 is selected, where 10 means "extremely" and 0 means "not at all".	1 month
Other	Epworth Sleepiness Scale (ESS)	Sleepiness Scale. Scales: 3 means "high chance of dozing", 2 means "moderate chance of dozing", 1 means "slight chance of dozing", and 0 means "would never doze".	1 month
Other	PROMIS Neuro-Quality of Life Fatigue Scale	Fatigue Scale. Scales: For each question, "Always" (5), "Often" (4), "Sometimes" (3), "Rarely" (2), and "Never" (1) is selected.	1 month
Other	PROMIS Neuro-Quality of Life Sleep Disturbance Scale	Sleep Disturbance Scale. Scales: For each question, "Always" (5), "Often" (4), "Sometimes" (3), "Rarely" (2), and "Never" (1) is selected.	1 month
Primary	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
Primary	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
Primary	Tidal volume measurements	(average measured tidal volume/average set tidal volume)*100%	1 month
Secondary	Interviews with subjects regarding their experience with the custom mask Qualitative assessment of custom NIV mask efficacy	Interviews with subjects regarding their experience with the custom mask	1 month