Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced Adoption
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
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Mass General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: Comfort
Participants in the Comfort Evaluation arm wore the SEEUS95 transparent reusable respirator to assess its comfort, fit, breathability, and usability during routine activities. The respirator features a transparent facepiece, reusable silicone body, skin-safe adhesive facial seal, and replaceable high-efficiency bio-filter. Participants completed both short-duration (approximately 30-minute) and extended-duration wear evaluations and completed standardized questionnaires assessing overall comfort, ease of breathing, facial seal, pressure points, communication, visibility of facial expressions, and overall user satisfaction. Qualitative feedback was also collected regarding perceived comfort, willingness to use the respirator in healthcare and public settings, and recommendations for design improvements. The evaluation included both short-term (30-minute) and extended-duration wear to assess changes in comfort and usabilit |
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. |
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Aktivní komparátor: Visual and facial identity
Compare facial recognition with Seeus95 mask and comparative mask with N95 rating most commonly used in the market.
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Comfort
Časové okno: 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. |
30 min - 1 hour
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Alice Chun, SEEUS95 Inc
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 392464
- 1R41DC020133-01A1 Appl ID 1048 (Jiné číslo grantu/financování: Harvard University Faculty of Medicine)
- 1R41DC020133-01A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
What Individual Participant Data (IPD) will be shared?
De-identified individual participant data underlying the results reported in publications arising from this study will be made available. The shared dataset may include participant demographic information, usability questionnaire responses, comfort assessments, breathability ratings, communication and visibility evaluations, and other de-identified outcome measures collected during the study.
What other documents will be available?
The following supporting documents may also be made available:
Study protocol Statistical analysis plan (if applicable) Case report forms (with identifying information removed) Data dictionary describing variables and coding Informed consent template (redacted as appropriate) When will the data be available?
Data will become available beginning 6 months after publication of the primary study results or 12 months after study completion, whichever occurs first.
How long will the data be available?
T
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
De-identified individual participant data and supporting study documents will be made available to qualified researchers upon reasonable request. Access may include de-identified participant-level usability data, study protocol, data dictionary, and statistical analysis documentation, as applicable.
Researchers requesting access must submit a brief research proposal describing the intended use of the data. Requests will be reviewed by the Principal Investigator to ensure that the proposed use is scientifically appropriate, consistent with participant informed consent, and protects participant confidentiality. Approved investigators may be required to execute a Data Use Agreement prior to receiving the data.
Requests should be directed to the Principal Investigator at SEEUS95 Inc. Data will be provided electronically using a secure file transfer method.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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