Clinical trial NCT06570161: Assessment of Fit of Novel N95 Style Transparent Face Masks
Official title: Assessment of User Preference and Fit of Novel Transparent Face Masks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Disease
Infection, Coronavirus
Respiratory Tract Infections
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Face masks have become a critically important public health intervention after the COVID-19 pandemic. Multiple types of masks ranging from full face filtering to cloth masks have been developed and commercialized to facilitate protection against respiratory pathogens. Most of these systems are made with opaque fabrics and may prevent individuals from expressing emotions or for those who are deaf and hard of hearing, communicating. To date, few transparent face masks which also confer respiratory pathogen protection have been developed. This study will test the feasability and acceptability of two new masks, the SEEUS-95 mask and CrystalGuard mask which are both transparent versions of N-95 filtering face masks.

Detailed description: This is a randomized crossover trial to evaluate the feasibility, acceptability and choice between the use of the SEEUS-95, CrystalGuard transparent face masks or a standard N95 mask. Otherwise healthy individuals will be prescreened and then scheduled for a single study visit. Participants will be randomized to wear each of the three masks (SEEUS-95, CrystalGuard, N95). They will be taught how to wear the mask, and we will assist participants with correctly wearing the mask for a good fit. Next, participants will undergo standard FIT testing where a clear hood will be placed over the participant's head, and a bitter solution (Bitrex) is sprayed into the hood. A positive test is indicated if the participant is able to taste Bitrex demonstrating that there is a detected leak within the mask. After a few minute washout period, participants will undergo FIT testing of subsequent masks. We will ask participants to rate the comfort of wearing the masks, willingness to wear masks in public and suggestions for improvement in mask design. Finally, we will conduct a discrete choice test to ask participants which mask they would prefer to wear in public.

Eligibility criteria: Inclusion Criteria:

* \>18 years old
* No history of asthma, restrictive lung disease, interstitial lung disease, or emphysema
* Lack of significant facial hair that precludes wearing a N-95 mask

Exclusion Criteria:

* Less than 18 years old
* Unable to smell Bitrex solution used for fit testing

Primary outcomes:
measure: Acceptability
timeFrame: immediately after mask wearing
Secondary outcomes:
measure: Mask preference
timeFrame: immediately after completion of all three arms
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Peter Chai, MD
role: PRINCIPAL_INVESTIGATOR
References: