Amyotrophic Lateral SclerosisNCT03519880
A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
A study testing Custom Mask Interface in people with Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Custom Mask Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 14 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
Who cannot join
- Subjects successfully using a commercially available mask without objective or subjective leak with good compliance (average use >6 hours per night)
- Silicone allergy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Custom Mask Interface
- Keywords
- amyotrophic lateral sclerosis, non-invasive ventilation, mask, custom, 3D-printing
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Mask InterfaceDevice
Subjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Custom Mask Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Tidal volume measurements
(average measured tidal volume/average set tidal volume)*100%
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start14 Mar 2017
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
Why it stopped: COVID-19 research restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All trial enrollees will receive the custom-designed 3D printed non-invasive ventilation mask interface.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association
- Responsible party
- Principal investigator, Stephen Goutman, University of Michigan
- Investigators
- Stephen A Goutman, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519880
- Sponsor's protocol ID
- HUM00112433
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
- ClinicalTrials.gov ID
- NCT03519880
- Acronym / sponsor ID
- HUM00112433
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, non-invasive ventilation, mask, custom, 3D-printing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 research restrictions
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- ALS Association
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All trial enrollees will receive the custom-designed 3D printed non-invasive ventilation mask interface.
| Arm | Type | Receives |
|---|---|---|
| Custom Mask Interface | Experimental | Device: Custom Mask InterfacePatients use a custom mask interface for one month with an option to use for a year if it performs better than a commercial mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects successfully using a commercially available mask without objective or subjective leak with good compliance (average use >6 hours per night)
- Silicone allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom Mask InterfaceSubjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface. | Device | Custom Mask Interface |
Primary outcome
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%
1 secondary outcome
Interviews with subjects regarding their experience with the custom mask Qualitative assessment of custom NIV mask efficacy
Time frame: 1 month
Results and safety
The study was stopped early (reason given: COVID-19 research restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Goutman, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom Mask Interface in people with Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 research restrictions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of hours the custom NIV mask interface is used per night (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.