Covid19NCT04826809
New Reusable Mask Design With Superior Filtration and Fit
A study testing N95 mask, Nordell single E-100 layer mask and Nordell double E-100 layer mask in people with Covid19 and Tuberculosis, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Tuberculosis, Respiratory Viral Infection
- What is being tested?
- N95 mask, Nordell single E-100 layer mask and Nordell double E-100 layer mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current employee of Mayo Clinic Health System-Mankato
- Passed N95 fit test within the past year
- No medical history of: high blood pressure, current or recent pneumonia or upper respiratory infection, and no uncontrolled chronic asthma
- Ideally with wide representation of genders, race, age, BMI, occupation/role in hospital.
- Willing and able to provde verbal consent.
Who cannot join
- History of uncontrolled asthma, pneumonia, or hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System in Mankato
Mankato, Minnesota, 56001
About this study
Official title: A New Fully-reusable, Affordable, Comfortable Mask Design With Superior Filtration and Fit for Use During Respirator Shortages and Pandemics
This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable.
Read the detailed description
The purpose of this study is to determine potential effectiveness of a new, reusable mask against SARS-CoV-2 and other microbes. This requires filtering down to at least 0.3 microns, as the SARS-CoV-2 virus is on average 0.25-0.5 microns in diameter.
Dr. Nordell has developed a machine-washable mask which shows potential to be significantly more effective than other masks on the market. It uses a fabric that is machine washable, without need for a filter or replaceable component. This fabric, Evolon-100 or E-100, is a microfilament fabric produced by a private company outside of the USA (and is therefore not yet FDA approved as of December 2020).
Unofficial data shows this mask passes the "N95 fit test" before and after multiple washes on the majority of individuals tested, and the material used in Dr. Nordell's design filters 93-96% of 0.3 micron particles. For reference, the N95 mask used in the hospital (whenever concern for potential exposure to COVID-19 or similar contagion exists) filters 95% of 0.3 micron particles when factoring in air leak, assessed with the "fit test." Voluntary survey of users also shows it is more comfortable than other masks, including the N95. This mask is also reported to be breathable even after prolonged use.
This mask design addresses every factor in respirator design. The design intentionally uses pleats to increase the effective mask surface area while decreasing the seal perimeter, resulting in increased air flow, lower pressure drop, and increased filtration efficiency. The investigators propose that it has a higher filtration ability than other washable fabrics tested, filtering at least 93% of 0.3 micron particles, even up to 96%. It also helps prevent air leak, a large factor limiting efficacy of most non-standard masks. It is easy to don and doff, and it is very easy to clean and disinfect. This material can be washed multiple times in a standard washing machine without reducing its effectiveness. And finally, it is very affordable, with materials for one mask costing less than $1.50. All materials used beyond this specific fabric are easily purchased on the internet or in a fabric store.
Upon completion of this research, the investigators hope to demonstrate that this mask is a superior alternative in multiple settings, including hospitals in developing countries with little or no N95 mask access, non-hospital settings such as businesses and schools, as well as for the general population, especially those with high risk for COVID-related complications.
- Conditions
- Covid19, Tuberculosis, Respiratory Viral Infection
- Being tested
- N95 mask, Nordell single E-100 layer mask, Nordell double E-100 layer mask
- Keywords
- PPE, mask, N95, pandemic, mask shortage
- Medical subject headings
- COVID-19, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 maskDevice
Standard 1870 N95 one time use mask
Nordell single E-100 layer maskDevice
Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay
Nordell double E-100 layer maskDevice
Nordell mask design using two layers of E-100 fabric
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | Experimental | Health care workers will complete a fit test while wearing the Nordell Single E-100 layer + (cotton layer) mask, Nordell Double E-100 layer mask and an N95 mask Receives: Device: N95 mask; Device: Nordell single E-100 layer mask; Device: Nordell double E-100 layer mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Fit Tests
Number of participants to pass the respirator fit testing using Bitrix solution. If participants do not smell or taste the solution while wearing the respirator it is considered passed.
Measured: Baseline
Comfort Level of Nordell Double E-100 Layer Mask
Measured by a self-reported questionnaire that rates the comfort level of the Nordell Double E-100 layer mask on a scale from 0 to 5 (0 is the most uncomfortable mask ever worn, 5 is the best, most comfortable mask)
Measured: Baseline
Ability to Breathe With Nordell Double E-100 Layer Mask
Measured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the Nordell Double E-100 Layer Mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start9 Apr 2021
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janielle R. Nordell, Mayo Clinic
- Investigators
- Janielle R Nordell, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826809
- Sponsor's protocol ID
- 20-011897
- Status last verified
- Jun 2023
- First submitted
- 18 Mar 2021
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Fully-reusable, Affordable, Comfortable Mask Design With Superior Filtration and Fit for Use During Respirator Shortages and Pandemics
- ClinicalTrials.gov ID
- NCT04826809
- Acronym / sponsor ID
- 20-011897
- Conditions
- Covid19, Tuberculosis, Respiratory Viral Infection
- Keywords
- PPE, mask, N95, pandemic, mask shortage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable.
Detailed description
The purpose of this study is to determine potential effectiveness of a new, reusable mask against SARS-CoV-2 and other microbes. This requires filtering down to at least 0.3 microns, as the SARS-CoV-2 virus is on average 0.25-0.5 microns in diameter.
Dr. Nordell has developed a machine-washable mask which shows potential to be significantly more effective than other masks on the market. It uses a fabric that is machine washable, without need for a filter or replaceable component. This fabric, Evolon-100 or E-100, is a microfilament fabric produced by a private company outside of the USA (and is therefore not yet FDA approved as of December 2020).
Unofficial data shows this mask passes the "N95 fit test" before and after multiple washes on the majority of individuals tested, and the material used in Dr. Nordell's design filters 93-96% of 0.3 micron particles. For reference, the N95 mask used in the hospital (whenever concern for potential exposure to COVID-19 or similar contagion exists) filters 95% of 0.3 micron particles when factoring in air leak, assessed with the "fit test." Voluntary survey of users also shows it is more comfortable than other masks, including the N95. This mask is also reported to be breathable even after prolonged use.
This mask design addresses every factor in respirator design. The design intentionally uses pleats to increase the effective mask surface area while decreasing the seal perimeter, resulting in increased air flow, lower pressure drop, and increased filtration efficiency. The investigators propose that it has a higher filtration ability than other washable fabrics tested, filtering at least 93% of 0.3 micron particles, even up to 96%. It also helps prevent air leak, a large factor limiting efficacy of most non-standard masks. It is easy to don and doff, and it is very easy to clean and disinfect. This material can be washed multiple times in a standard washing machine without reducing its effectiveness. And finally, it is very affordable, with materials for one mask costing less than $1.50. All materials used beyond this specific fabric are easily purchased on the internet or in a fabric store.
Upon completion of this research, the investigators hope to demonstrate that this mask is a superior alternative in multiple settings, including hospitals in developing countries with little or no N95 mask access, non-hospital settings such as businesses and schools, as well as for the general population, especially those with high risk for COVID-related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health care workers | Experimental | Device: N95 mask, Device: Nordell single E-100 layer mask, Device: Nordell double E-100 layer maskHealth care workers will complete a fit test while wearing the Nordell Single E-100 layer + (cotton layer) mask, Nordell Double E-100 layer mask and an N95 mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current employee of Mayo Clinic Health System-Mankato
- Passed N95 fit test within the past year
- No medical history of: high blood pressure, current or recent pneumonia or upper respiratory infection, and no uncontrolled chronic asthma
- Ideally with wide representation of genders, race, age, BMI, occupation/role in hospital.
- Willing and able to provde verbal consent.
Key exclusion criteria (1 listed)
- History of uncontrolled asthma, pneumonia, or hypertension.
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 |
|---|---|---|
| N95 maskStandard 1870 N95 one time use mask | Device | Health care workers |
| Nordell single E-100 layer maskNordell mask design using one layer of E-100 fabric plus cotton fabric overlay | Device | Health care workers |
| Nordell double E-100 layer maskNordell mask design using two layers of E-100 fabric | Device | Health care workers |
Primary outcome
Comparison of Fit Tests
Time frame: Baseline
Number of participants to pass the respirator fit testing using Bitrix solution. If participants do not smell or taste the solution while wearing the respirator it is considered passed.
Comfort Level of Nordell Double E-100 Layer Mask
Time frame: Baseline
Measured by a self-reported questionnaire that rates the comfort level of the Nordell Double E-100 layer mask on a scale from 0 to 5 (0 is the most uncomfortable mask ever worn, 5 is the best, most comfortable mask)
Ability to Breathe With Nordell Double E-100 Layer Mask
Time frame: Baseline
Measured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the Nordell Double E-100 Layer Mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Janielle R Nordell, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N95 mask, Nordell single E-100 layer mask and Nordell double E-100 layer mask in people with Covid19 and Tuberculosis, run by Mayo Clinic 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Fit Tests (time frame: Baseline). 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 7 Jul 2023.