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Product Testing of the FaceView Mask™: Usability Survey

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ClinicalTrials.gov Identifier: NCT04854694
Recruitment Status : Not yet recruiting
First Posted : April 22, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The study aims to gather participants' perceptions of the novel transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following fitting of the masks, participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.

Condition or disease Intervention/treatment Phase
Hearing Disability Device: FaceView Mask™ Device: conventional surgical N95 respirator Not Applicable

Detailed Description:
The investigators will recruit adult participants to complete a usability survey on a transparent surgical N95 respirator (i.e., FaceView mask) designed to improve communication. The study aims to gather participants' perceptions of the novel transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following fitting of the masks (5 minutes wear time each), the participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will try on both the FaceView Mask™ and the conventional surgical N95 respirator in quasi-random order from participant to participant and provide feedback via survey afterward.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Product Testing of the FaceView Mask™: Usability Survey
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: All Subjects

All participants will be fit tested for the masks to ensure that the appropriate size is used. Some participants will wear the FaceView Mask™ (first) for 5 minutes before wearing the conventional surgical N95 respirator for 5 minutes. Others will wear the conventional surgical N95 respirator (first) for 5 minutes before wearing the FaceView Mask™ for 5 minutes.

All subjects will complete the study survey after exposure to the interventions.

Device: FaceView Mask™
transparent surgical N95 respirator designed to improve communication

Device: conventional surgical N95 respirator
standard N95 respirator




Primary Outcome Measures :
  1. ease of understanding another person [ Time Frame: 1 day ]

    As recorded on the survey

    1. Difficult
    2. Somewhat difficult
    3. Somewhat easy
    4. Easy


Secondary Outcome Measures :
  1. fit of the mask [ Time Frame: 1 day ]

    As recorded on the survey

    1. Extremely small
    2. Slightly too small
    3. Fits well
    4. Slightly too large
    5. Extremely large

  2. comfort of the mask [ Time Frame: 1 day ]

    As recorded on the survey

    1. Not comfortable at all
    2. Slightly comfortable
    3. Very comfortable
    4. Extremely comfortable

  3. ease of breathing [ Time Frame: 1 day ]

    As recorded on the survey

    1. Not easy at all
    2. Slightly breathable
    3. Very breathable
    4. Extremely breathable

  4. ease of speaking/communicating [ Time Frame: 1 day ]

    As recorded on the survey

    1. Difficult
    2. Somewhat difficult
    3. Somewhat easy
    4. Easy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 18 years old
  • have no health conditions that would prevent them from safely wearing an N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)
  • read in English and communicate in English or American Sign Language
  • be able to provide or arrange their own transportation to the study location

Exclusion Criteria:

  • Children are to be excluded from the proposed research project because the current FaceView Mask™ is designed for adults
  • Adults who are non-English communicators
  • Any adult with health conditions that would prevent them from safely wearing an N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)

Information from the National Library of Medicine

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): NCT04854694


Contacts
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Contact: Samuel R Atcherson, Ph.D. 501-686-6860 sratcherson@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Contact: Samuel R Atcherson, Ph.D.    501-686-6860    sratcherson@ualr.edu   
Principal Investigator: Samuel R Atcherson, Ph.D.         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Samuel R Atcherson, PhD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04854694    
Other Study ID Numbers: 262478
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Arkansas:
lip reading
face mask