Hearing DisabilityNCT04854694

Product Testing of the FaceView Mask™: Usability Survey

An observational study of Hearing Disability, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hearing Disability
What is being tested?: FaceView Mask™ and conventional surgical N95 respirator
Type of treatment: Medical device
How many people: 202 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2022to 29 Feb 2024
Phase: Observational
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

Study population: A goal of 200 participants is desired with a minimum of 125 to meet study targets. We will be contacting known persons (not cold contacts) with ability to share study brochure by e-mail: 1. across the UAMS campus (e.g., College Deans, Center Directors, Program Directors); 2. surrounding clinics; 3. American Sign Language interpreter education at the University of Arkansas at Little Rock (Program Director) 4. Arkansas School for the Deaf (Superintendent and/or Assistant to the Superintendent); and 5. Communications Plus+ Interpreter Services, Inc. (owner and operator)

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205

Other trials in United States

About this study

Read the 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.

Conditions: Hearing Disability
Being tested: FaceView Mask™, conventional surgical N95 respirator
Keywords: lip reading, face mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FaceView Mask™Device
transparent surgical N95 respirator designed to improve communication
conventional surgical N95 respiratorDevice
standard N95 respirator

Study groups in NCT04854694
Study group	Role	What they receive
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. Receives: Device: FaceView Mask™; Device: conventional surgical N95 respirator

What is being measured

The primary outcome is the main question the study is designed to answer.

Ease of Understanding Another Person
As recorded on the survey
1. Difficult
2. Somewhat difficult
3. Somewhat easy
4. Easy
Measured: 1 day

Secondary outcomes (4)

Fit of the Mask
As recorded on the survey
1. Extremely small
2. Slightly too small
3. Fits well
4. Slightly too large
5. Extremely large
Measured: 1 day
Comfort of the Mask
As recorded on the survey
1. Not comfortable at all
2. Slightly comfortable
3. Very comfortable
4. Extremely comfortable
Measured: 1 day
Ease of Breathing
As recorded on the survey
1. Not easy at all
2. Slightly breathable
3. Very breathable
4. Extremely breathable
Measured: 1 day
Ease of Speaking/Communicating
As recorded on the survey
1. Difficult
2. Somewhat difficult
3. Somewhat easy
4. Easy
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202229 Feb 2024

First posted22 Apr 2021
Study start15 Nov 2022
Primary completion29 Feb 2024
Study completion29 Feb 2024

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 Hearing DisabilityStudies of the same condition, open and under way.
More trials run by University of ArkansasThe 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: Other
Time perspective: Prospective
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04854694
Sponsor's protocol ID: 262478
Status last verified: Mar 2025
First submitted: 16 Apr 2021
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Disability trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Product Testing of the FaceView Mask™: Usability Survey
ClinicalTrials.gov ID: NCT04854694
Acronym / sponsor ID: 262478
Conditions: Hearing Disability
Keywords: lip reading, face mask
Study type: Observational
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Study start: 15 Nov 2022 (actual)
Primary completion: 29 Feb 2024 (actual)
Study completion: 29 Feb 2024 (actual)
First posted: 22 Apr 2021 (actual)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Subjects	–	Device: FaceView Mask™, Device: conventional surgical N95 respiratorAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: A goal of 200 participants is desired with a minimum of 125 to meet study targets. We will be contacting known persons (not cold contacts) with ability to share study brochure by e-mail: 1. across the UAMS campus (e.g., College Deans, Center Directors, Program Directors); 2. surrounding clinics; 3. American Sign Language interpreter education at the University of Arkansas at Little Rock (Program Director) 4. Arkansas School for the Deaf (Superintendent and/or Assistant to the Superintendent); and 5. Communications Plus+ Interpreter Services, Inc. (owner and operator)

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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)

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
FaceView Mask™transparent surgical N95 respirator designed to improve communication	Device	All Subjects
conventional surgical N95 respiratorstandard N95 respirator	Device	All Subjects

Primary outcome

Ease of Understanding Another Person
Time frame: 1 day
As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy

4 secondary outcomes

Fit of the Mask
Time frame: 1 day
Comfort of the Mask
Time frame: 1 day
Ease of Breathing
Time frame: 1 day
Ease of Speaking/Communicating
Time frame: 1 day

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transparent Mask First, Then Non-Transparent Mask	101	101
Non-Transparent Mask First, Then Transparent Mask	101	101

Primary outcome: Ease of Understanding Another Person

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Transparent Mask n = 202	Non-Transparent Mask n = 202
Difficult	0	24
Somewhat difficult	4	67
Somewhat easy	36	47
Easy	162	64

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transparent Mask	0 of 202 (0%)	0 of 202 (0%)	0 of 202
Non-Transparent Mask	0 of 202 (0%)	0 of 202 (0%)	0 of 202

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hearing Disability

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Reduction of Anxiety Through Dual Treatment: Digital CBT & NBHWC Coaching
Hearing Disability, Anxiety
Not yet recruitingObservational study
How Can the Experience of Hospital Outpatient Departments be Improved?
Neurofibromatosis Type 1 (NF1), NF2-related Schwannomatosis
Not yet recruiting
Reduction of Depression Through Dual Treatment: Digital CBT & NBHWC Coaching
Hearing Disability, Depression
Recruiting
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
Fragile X Syndrome

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.

Samuel R Atcherson, PhD principal investigator

University of Arkansas

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 Hearing Disability, run by University of Arkansas 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 4 inclusion and 3 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 10 Apr 2025. 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 10 Apr 2025). 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?

Ease of Understanding Another Person (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854694.

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 10 Apr 2025.