Focus is on Healthy SubjectsNCT07711145
Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced Adoption
A study testing Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption in people with Focus is on Healthy Subjects, run by SEEUS95 Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus is on Healthy Subjects
- What is being tested?
- Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to 14 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Conditions
- Focus is on Healthy Subjects
- Being tested
- Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced AdoptionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Comfort | Other | 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 Receives: Device: Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption |
| Visual and facial identity | Active comparator | Compare facial recognition with Seeus95 mask and comparative mask with N95 rating most commonly used in the market. Receives: Device: Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
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.
Measured: 30 min - 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start26 Jun 2025
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus is on Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Volunteers will test mask for long and short periods to assess levels of comfort,
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEEUS95 Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alice Chun, Principal investigator, SEEUS95 Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711145
- Sponsor's protocol ID
- 392464
- Other IDs
- 1R41DC020133-01A1 Appl ID 1048, 1R41DC020133-01A1
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced Adoption
- ClinicalTrials.gov ID
- NCT07711145
- Acronym / sponsor ID
- 392464
- Conditions
- Focus is on Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SEEUS95 IncIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Volunteers will test mask for long and short periods to assess levels of comfort,
| Arm | Type | Receives |
|---|---|---|
| Comfort | Other | Device: Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced AdoptionParticipants 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 |
| Visual and facial identity | Active comparator | Device: Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced AdoptionCompare facial recognition with Seeus95 mask and comparative mask with N95 rating most commonly used in the market. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced AdoptionThe 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. | Device | Comfort, Visual and facial identity |
Primary outcome
Comfort
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. 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
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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.
Alice Chun principal investigator
SEEUS95 Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption in people with Focus is on Healthy Subjects, run by SEEUS95 Inc 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 7 inclusion and 9 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 17 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comfort (time frame: 30 min - 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.