Focus is on Healthy Subjects
Conditions
Brief 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
Interventions
DEVICEReusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption
The SEEUS95 is an investigational reusable transparent respirator designed to provide N95-equivalent respiratory protection while improving user comfort, communication, and sustainability. Unlike conventional opaque disposable respirators, the SEEUS95 incorporates a transparent facepiece that allows full visibility of the mouth and facial expressions, facilitating communication and lip-reading during patient care and everyday interactions. The respirator consists of a reusable medical-grade silicone body with a skin-safe adhesive facial seal designed to provide a secure fit across a wide range of facial shapes and sizes without the need for tight elastic straps. The device incorporates replaceable high-efficiency bio-based filter media and is intended to reduce environmental waste associated with single-use disposable respirators.
Sponsors
SEEUS95 Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Volunteers will test mask for long and short periods to assess levels of comfort,
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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. * Facial hair or facial anatomy that would prevent an adequate respirator seal. * Physical or cognitive impairment that would interfere with the ability to safely wear the respirator or complete study procedures. * Participation in another clinical study that, in the opinion of the investigator, could interfere with study participation or interpretation of the results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 30 min - 1 hour | Primary Outcome Measure Comfort While Wearing the SEEUS95 Transparent Respirator Mask Description: Participant-reported comfort of the SEEUS95 reusable transparent respirator mask during routine daily activities. Comfort will be assessed using a standardized user questionnaire evaluating overall fit, facial pressure, breathability, heat and moisture buildup, ease of speaking, ease of breathing, skin irritation, and overall wearability. Individual questionnaire items will be rated on a 10-point Likert scale (1 = very poor, 10 = excellent). An overall comfort score will be calculated as the mean of all comfort-related items. Time Frame: Immediately following a 15-minute wear period and again after prolonged use of 5-8 hours. Partial Breaks every 30 minutes. Assessment Method: Self-administered participant questionnaire completed after each testing period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlice Chun
SEEUS95 Inc
Outcome results
None listed