CompletedNot Applicable

Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced Adoption

United States20 participantsStarted 2025-06-26

Plain-language summary

The goal of this observational usability study was to evaluate the comfort, breathability, fit, communication, and user acceptance of the SEEUS95 transparent reusable respirator in healthy adult volunteers. The study aimed to assess whether a transparent respirator could improve the user experience while maintaining the characteristics expected of an N95-equivalent respirator. The main questions it aimed to answer were: Is the SEEUS95 transparent respirator comfortable to wear during both short-duration (30-minute) and extended-duration use? Does the transparent design improve communication and participants' perception of being seen and understood compared with conventional opaque respirators? Can participants breathe comfortably while wearing the SEEUS95 respirator? Does the adhesive sealing system provide a secure, comfortable fit across different facial shapes and sizes? What design improvements would increase user acceptance and long-term adoption? Researchers also collected qualitative feedback regarding facial visibility, social interaction, and overall satisfaction with the transparent respirator design. Participants Healthy adult volunteers, 18 years of age and older. Participants were asked to: Wear the SEEUS95 transparent respirator for approximately 30 minutes during routine activities. A subset of participants wore the respirator for an extended-duration evaluation to assess comfort over longer periods. Complete standardized questionnaires evaluating: Overall comfort Ease of breathing Facial fit and seal Communication while wearing the mask Visibility of facial expressions Perception of feeling "seen" while interacting with others Willingness to wear the respirator in healthcare, workplace, and public settings Overall satisfaction and recommendations for design improvements Provide qualitative feedback through interviews regarding usability, communication, and daily wear experience. Primary Outcome Measures Overall user comfort during respirator wear Ease of breathing Quality of fit and facial seal Communication effectiveness enabled by the transparent design User acceptance and likelihood of long-term adoption Secondary Outcome Measures Participant perception of social connection and facial visibility Skin comfort and pressure points Ease of donning and removing the respirator Recommendations for future design refinements

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults 18 years of age or older. * Able to understand the study procedures and provide written informed consent. * Willing and able to wear the SEEUS95 transparent respirator for approximately 30 minutes and, for selected participants, during an extended-duration wear evaluation. * Able to complete study questionnaires and provide verbal or written feedback regarding comfort, fit, breathability, communication, visibility, and usability. * In generally good health, with no medical condition that would preclude wearing a respirator for the duration of the evaluation. * Willing to comply with all study procedures and scheduled assessments. * Healthcare workers, clinical staff, or individuals with experience using respiratory protective equipment. Exclusion Criteria: * Under 18 years of age. * Unable or unwilling to provide written informed consent. * Known allergy or hypersensitivity to silicone, medical-grade adhesives, or other materials used in the SEEUS95 respirator. * Active respiratory infection or acute illness at the time of participation. * Significant respiratory disease or other medical condition that, in the opinion of the investigator, could make respirator use unsafe (including severe uncontrolled asthma, chronic obstructive pulmonary disease requiring supplemental oxygen, or severe cardiopulmonary disease). * Facial skin conditions, open wounds, burns, or dermatologic disorders that could be aggravated by wearing an adhesive respirator. * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comfort

Timeframe: 30 min - 1 hour

Trial details

NCT IDNCT07711145

SponsorSEEUS95 Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-14

View on ClinicalTrials.gov More Focus is on Healthy Subjects trials