FFP3-RAE: FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing

Sponsor

Liverpool University Hospitals NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05222230

Collaborator

(none)

Enrollment

Arm

5.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is Prospective Basic Science Study whose aims are as follows:

To determine the effect of Filtering Facepiece (FFP3M) respirators on eustachian tube function and hearing
To evaluate the extent to which FFP3M respirators attenuate speech in decibels

The outcome measures are as follows:

Changes in baseline pure tone audiometry and tympanometry post intervention.
SNOT-22 Questionnaires before and after use of respirator
ETDQ7 questionnaire
Measurement of speech attenuation in decibels.

Condition or Disease	Intervention/Treatment	Phase
Eustachian Tube Dysfunction Hearing Disorders Nasal Obstruction	Other: FFP3 Mask	N/A

Detailed Description

The use of facemasks is one of the key strategies for reducing human to human transmission of SARS-CoV-2. There is a variety of facemasks worn in the clinical environment ranging from simple facemasks to devices such as filtering face piece 3M (FFP3M) respirators which are mandatory for some clinicians performing aerosol generating procedures (AGPs.)

It has been shown that wearing face protective equipment attenuates sound causing decay in speech intelligibility, especially transmission of middle-to-high voice frequencies.It has been shown that wearing surgical masks results in up to 23.3% loss of speech intelligibility in noisy environments with advanced face personal protective equipment such as FFP3M devices, accounting for up to 69.0% reduction of speech intelligibility. A reduction in speech intelligibility leads to reduced understanding which may result in miscommunication thereby compromising patient safety. To date, there have been two critical incidents in our department due to miscommunication attributed to wearing FFP3M respirators.

Anecdotally, clinicians have reported nasal congestion and subjective hearing loss during FFP3M respirator usage and after, especially when they are worn for a prolonged period of time. Clinicians working in theatre may be required to wear these devices for a number of hours when involved with AGPs.

The secondary consequences of wearing FFP3M respirators for prolonged periods of time, especially in a theatre setting require scientific exploration. This study aims to investigate the effect of FFP3M respirators on middle ear pressure and hearing, and the extent to which FFP3M respirators attenuate sound. Investigators believe that a reduction in speech intelligibility is not the only explanation for the perception of hearing loss when using FFP3M respirators. Investigators postulate that a transient dysfunction in the eustachian tube pressure regulating system also contributes to hearing loss.

To test this hypothesis, investigators will measure hearing and middle ear pressure using pure tone audiometry and tympanometry before and during FFP3M usage. Investigators will also use SNOT-22 and ETDQ7 questionnaires which are validated patient reported outcome measures for nasal symptoms and eustachian tube function. Investigators hope that this study provides some understanding of the physiological effects of FFP3M respirators on hearing and sinonasal symptoms and improves our understanding of their impact on clinical practice. There are no current studies looking into the effects of FFP3M respirators on eustachian tube function.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective open label basic science study.Prospective open label basic science study.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing

Anticipated Study Start Date :

Jul 23, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FFP3 Respirator Participants will wear FFP3 respirators during the study.	Other: FFP3 Mask Participans will wear FFP3 respirators during the study.

Arm

Intervention/Treatment

Experimental: FFP3 Respirator

Participants will wear FFP3 respirators during the study.

Other: FFP3 Mask

Participans will wear FFP3 respirators during the study.

Outcome Measures

Primary Outcome Measures

Changes in baseline pure tone audiometry post intervention. [48 hours]
We will measure changes in baseline pure tone audiometry post FFP3 respirator usage..
Measurement of speech attenuation in decibels. [1 hours]
We will measure speech attenuation in decibels when participants are wearing FFP3 respirators
Changes in baseline tympanometry post intervention [48 hours]
We will measure changes in baseline tympanometry post FFP3 respirator usage.

Secondary Outcome Measures

Eustachian tube function [48 hours]
Participants will complete the SINO-NASAL OUTCOME TEST (SNOT-22) Questionnaire which is a 22 point questionnaire. Participants will be asked to grade the severity of their symptoms from 1-5 with with higher scores denoting severe symptoms. The questionnaires will be completed pre and post interventions to investigate changes in eustachian tube function.
Eustachian tube function [48 hours]
Participants will complete the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) which is a 7 point questionnaire. Patients are asked to grade the severity of their symptoms from 1-7 with with higher scores denoting severe symptoms. The questionnaires will be completed pre and post interventions to investigate changes in eustachian tube function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthcare workers that already have their own masks, fitted and provided by the Trust for day-to-day clinical use
Participants without pre-existing sinonasal symptoms or previous sinonasal surgery
Participants without pre-existing hearing loss or a history of otological procedures

Exclusion Criteria:

Participants with pre-existing sinonasal symptoms or previous sinonasal surgery
Participants with pre-existing hearing loss or a history of otological procedures
Participants who do not satisfy the requirements set out in the pre-registration questionnaire