FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing (FFP3-RAE)
Primary Purpose
Eustachian Tube Dysfunction, Hearing Disorders, Nasal Obstruction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FFP3 Mask
Sponsored by
About this trial
This is an interventional basic science trial for Eustachian Tube Dysfunction focused on measuring FFP3M respirators, eustachian tube dysfunction, hearing loss, audiometry, tympanometry
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FFP3 Respirator
Arm Description
Participants will wear FFP3 respirators during the study.
Outcomes
Primary Outcome Measures
Changes in baseline pure tone audiometry post intervention.
We will measure changes in baseline pure tone audiometry post FFP3 respirator usage..
Measurement of speech attenuation in decibels.
We will measure speech attenuation in decibels when participants are wearing FFP3 respirators
Changes in baseline tympanometry post intervention
We will measure changes in baseline tympanometry post FFP3 respirator usage.
Secondary Outcome Measures
Eustachian tube function
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
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.
Full Information
NCT ID
NCT05222230
First Posted
September 20, 2021
Last Updated
May 27, 2022
Sponsor
Liverpool University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05222230
Brief Title
FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing
Acronym
FFP3-RAE
Official Title
FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 23, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction, Hearing Disorders, Nasal Obstruction
Keywords
FFP3M respirators, eustachian tube dysfunction, hearing loss, audiometry, tympanometry
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective open label basic science study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FFP3 Respirator
Arm Type
Experimental
Arm Description
Participants will wear FFP3 respirators during the study.
Intervention Type
Other
Intervention Name(s)
FFP3 Mask
Intervention Description
Participans will wear FFP3 respirators during the study.
Primary Outcome Measure Information:
Title
Changes in baseline pure tone audiometry post intervention.
Description
We will measure changes in baseline pure tone audiometry post FFP3 respirator usage..
Time Frame
48 hours
Title
Measurement of speech attenuation in decibels.
Description
We will measure speech attenuation in decibels when participants are wearing FFP3 respirators
Time Frame
1 hours
Title
Changes in baseline tympanometry post intervention
Description
We will measure changes in baseline tympanometry post FFP3 respirator usage.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Eustachian tube function
Description
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.
Time Frame
48 hours
Title
Eustachian tube function
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazia Munir, FRCS ORL-HNS
Phone
07970921448
Email
nazir.munir@liverpoolft.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Kanzara, FRCS ORL-HNS
Phone
07796945100
Email
todd.kanzara@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with other researchers
Citations:
PubMed Identifier
33138498
Citation
Corey RM, Jones U, Singer AC. Acoustic effects of medical, cloth, and transparent face masks on speech signals. J Acoust Soc Am. 2020 Oct;148(4):2371. doi: 10.1121/10.0002279.
Results Reference
background
PubMed Identifier
33389012
Citation
Muzzi E, Chermaz C, Castro V, Zaninoni M, Saksida A, Orzan E. Short report on the effects of SARS-CoV-2 face protective equipment on verbal communication. Eur Arch Otorhinolaryngol. 2021 Sep;278(9):3565-3570. doi: 10.1007/s00405-020-06535-1. Epub 2021 Jan 3.
Results Reference
background
PubMed Identifier
32641175
Citation
Hampton T, Crunkhorn R, Lowe N, Bhat J, Hogg E, Afifi W, De S, Street I, Sharma R, Krishnan M, Clarke R, Dasgupta S, Ratnayake S, Sharma S. The negative impact of wearing personal protective equipment on communication during coronavirus disease 2019. J Laryngol Otol. 2020 Jul;134(7):577-581. doi: 10.1017/S0022215120001437. Epub 2020 Jul 28.
Results Reference
background
PubMed Identifier
19793277
Citation
Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
Results Reference
background
PubMed Identifier
22374681
Citation
McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. 2012 May;122(5):1137-41. doi: 10.1002/lary.23223. Epub 2012 Feb 28.
Results Reference
background
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FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing
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