A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03519880|
Recruitment Status : Enrolling by invitation
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: Custom Mask Interface||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All trial enrollees will receive the custom-designed 3D printed non-invasive ventilation mask interface.|
|Masking:||None (Open Label)|
|Masking Description:||There is no masking.|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects|
|Actual Study Start Date :||March 14, 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: 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.
Device: Custom Mask Interface
Subjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface.
- Average number of hours the custom NIV mask interface is used per night [ Time Frame: 1 month ]Average number of hours the custom NIV mask interface is used per night
- Leak parameters from device [ Time Frame: 1 month ]Average minutes in large leak or leak measured from the device in liters per minute and averaged over the month
- Tidal volume measurements [ Time Frame: 1 month ](average measured tidal volume/average set tidal volume)*100%
- Interviews with subjects regarding their experience with the custom mask Qualitative assessment of custom NIV mask efficacy [ Time Frame: 1 month ]Interviews with subjects regarding their experience with the custom mask
- ALS Depression Inventory-12 (ADI-12) [ Time Frame: 1 month ]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"
- ALS Functional Rating Scale, Revised (ALSFRS-R) [ Time Frame: 1 month ]Functional Rating Scale. Scales: Customized for each question, but 4 is the maximum and generally means 'normal', and 0 represents significant impairment.
- ALS Specific Quality of Life-20 (ALSSQOL20) [ Time Frame: 1 month ]Quality of Life Scale. Scales: For each question, 1-10 is selected, where 10 means "extremely" and 0 means "not at all".
- Epworth Sleepiness Scale (ESS) [ Time Frame: 1 month ]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".
- PROMIS Neuro-Quality of Life Fatigue Scale [ Time Frame: 1 month ]Fatigue Scale. Scales: For each question, "Always" (5), "Often" (4), "Sometimes" (3), "Rarely" (2), and "Never" (1) is selected.
- PROMIS Neuro-Quality of Life Sleep Disturbance Scale [ Time Frame: 1 month ]Sleep Disturbance Scale. Scales: For each question, "Always" (5), "Often" (4), "Sometimes" (3), "Rarely" (2), and "Never" (1) is selected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519880
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Stephen A Goutman, MD||University of Michigan|