Product Testing of the FaceView Mask™: Usability Survey

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing

NCT05222230

Eustachian Tube Dysfunction Hearing Disorders Nasal Obstruction

UNKNOWN NA

Visual Acoustic Biofeedback for RSE Via Telepractice

NCT04858022

Speech Sound Disorder

COMPLETED PHASE2

Evaluation of Hearing Aid Benefit

NCT05198713

Hearing Loss, Sensorineural

COMPLETED NA

Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

NCT02298452

Hearing Loss, Bilateral or Unilateral

COMPLETED NA

Audiological Assessment of Recovered Covid 19 Subjects.

NCT05052320

Covid 19

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Disability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

FaceView Mask™

Intervention Type DEVICE

transparent surgical N95 respirator designed to improve communication

conventional surgical N95 respirator

Intervention Type DEVICE

standard N95 respirator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FaceView Mask™

transparent surgical N95 respirator designed to improve communication

Intervention Type DEVICE

conventional surgical N95 respirator

standard N95 respirator

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes