Covid19NCT04733677
User Experience of the OSR M-1
An observational study of Covid19, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this observational study is to verify the user acceptance of the Open Standard Respirator-Model 1 (OSR-M1) by clinicians through pre-trial survey and quantitative fit-testing and post-trial feedback surveys. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 15 Nov 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Clinical staff who are issued and routinely wear N95 FFR may be screened.
Who may be able to join
- Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are eligible.
Who cannot join
- Participants unable to pass the fit testing will be excluded from the study.
- Anyone with a contraindication to wearing an N95 FFR (I.e. pregnancy, underlying medical conditions) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings
The purpose of this observational study is to verify the user acceptance of the Open Standard Respirator-Model 1 (OSR-M1) by clinicians through pre-trial survey and quantitative fit-testing and post-trial feedback surveys. This study will help to guide further design modifications and clarify quantities of employee populations that may benefit from elastomeric respirator use for the deployment of OSR M1 Air Purifying Respirators (APRs) in the Wake Health network.
Read the detailed description
The study team hypothesizes that the OSR M-1 APR with National Institute for Occupational Safety and Health classification 99% Airborne Particle Filtration (N99) will have increased fit and seal as well as user comfort and acceptance over disposable National Institute for Occupational Safety and Health classification 95% Airborne Particle Filtration (N95) filter facepiece respirators (FFR). The study team is proposing to assess the acceptance and functional usability of the OSR-M1 in Wake Forest Baptist Health System as a N95 disposable FFR alternative for improved protection and economy.
- Assess the effectiveness and causation of successful/unsuccessful fit testing of the OSR M1 APR by measuring anthropometry of facial features and performing quantitative fit testing of clinicians.
- Determine usability, initial and long-term acceptance of the OSR M1 APR relative to standard issue disposable FFRs through user survey and assessment.
- Conditions
- Covid19
- Keywords
- COVID, coronavirus, respirator, mask, N99
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSR M-1 N95 | All subjects will be fitted with an OSR M1 N95 mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Successful Fits
Percentage of subjects that pass fit-factor testing [0%-100%]
Measured: Day 1
Quality of Fit Score
Scores can range from 0 to 10000 with a higher score denoting a better fit. A score of 100 qualifies as a successful OSHA half-mask respirator fit test.
Measured: Day 1
Percentage of Participants that Fit in a Small Size Mask
percentage [0%-100%]
Measured: Day 1
Percentage of Participants that fit in a Medium Size Mask
percentage [0%-100%]
Measured: Day 1
Percentage of Participants that fit in a Large Size Mask
percentage [0%-100%]
Measured: Day 1
User Acceptance Percentage
Percentage of participants that prefer the experimental device over currently used device [0-100%]
Measured: Day 10
Secondary outcomes (1)
Percentage of Impression Change
Changes in impression of the device (pre-trial vs. post-trial) - percentage of positive or negative change [-100% - +100%]
Measured: Baseline through Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start19 Mar 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Why it stopped: NIOSH certification became impossible, so decision was made to terminate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip J Brown, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733677
- Sponsor's protocol ID
- IRB00070715
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2021
- Last updated
- 30 Mar 2023
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings
- ClinicalTrials.gov ID
- NCT04733677
- Acronym / sponsor ID
- IRB00070715
- Conditions
- Covid19
- Keywords
- COVID, coronavirus, respirator, mask, N99
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: NIOSH certification became impossible, so decision was made to terminate
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Feb 2021 (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.
The purpose of this observational study is to verify the user acceptance of the Open Standard Respirator-Model 1 (OSR-M1) by clinicians through pre-trial survey and quantitative fit-testing and post-trial feedback surveys. This study will help to guide further design modifications and clarify quantities of employee populations that may benefit from elastomeric respirator use for the deployment of OSR M1 Air Purifying Respirators (APRs) in the Wake Health network.
Detailed description
The study team hypothesizes that the OSR M-1 APR with National Institute for Occupational Safety and Health classification 99% Airborne Particle Filtration (N99) will have increased fit and seal as well as user comfort and acceptance over disposable National Institute for Occupational Safety and Health classification 95% Airborne Particle Filtration (N95) filter facepiece respirators (FFR). The study team is proposing to assess the acceptance and functional usability of the OSR-M1 in Wake Forest Baptist Health System as a N95 disposable FFR alternative for improved protection and economy.
- Assess the effectiveness and causation of successful/unsuccessful fit testing of the OSR M1 APR by measuring anthropometry of facial features and performing quantitative fit testing of clinicians.
- Determine usability, initial and long-term acceptance of the OSR M1 APR relative to standard issue disposable FFRs through user survey and assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSR M-1 N95 | – | –All subjects will be fitted with an OSR M1 N95 mask |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical staff who are issued and routinely wear N95 FFR may be screened.
Key inclusion criteria (1 listed)
- Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are eligible.
Key exclusion criteria (2 listed)
- Participants unable to pass the fit testing will be excluded from the study.
- Anyone with a contraindication to wearing an N95 FFR (I.e. pregnancy, underlying medical conditions) will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Successful Fits
Time frame: Day 1
Percentage of subjects that pass fit-factor testing [0%-100%]
Quality of Fit Score
Time frame: Day 1
Scores can range from 0 to 10000 with a higher score denoting a better fit. A score of 100 qualifies as a successful OSHA half-mask respirator fit test.
Percentage of Participants that Fit in a Small Size Mask
Time frame: Day 1
percentage [0%-100%]
Percentage of Participants that fit in a Medium Size Mask
Time frame: Day 1
percentage [0%-100%]
Percentage of Participants that fit in a Large Size Mask
Time frame: Day 1
percentage [0%-100%]
User Acceptance Percentage
Time frame: Day 10
Percentage of participants that prefer the experimental device over currently used device [0-100%]
1 secondary outcome
Percentage of Impression Change
Time frame: Baseline through Day 10
Results and safety
The study was stopped early (reason given: NIOSH certification became impossible, so decision was made to terminate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Philip J Brown, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Wake Forest University Health Sciences 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 1 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 30 Mar 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?
The study was stopped early (reason given: NIOSH certification became impossible, so decision was made to terminate). 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?
Percentage of Successful Fits (time frame: Day 1). The study lists 6 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 30 Mar 2023.