Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-29 @ 4:44 PM
Study NCT ID:
NCT06570161
Status:
WITHDRAWN
Last Update Posted:
2025-07-28
First Post:
2024-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Fit of Novel N95 Style Transparent Face Masks
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Assessment of User Preference and Fit of Novel Transparent Face Masks
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: