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Eustachian Tube DysfunctionFFP3-RAENCT05222230

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

A study testing FFP3 Mask in people with Eustachian Tube Dysfunction and Hearing Disorders, run by Liverpool University Hospitals NHS Foundation Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is Prospective Basic Science Study whose aims are as follows: 1. To determine the effect of Filtering Facepiece (FFP3M) respirators on eustachian tube function and hearing 2. To evaluate the extent to which FFP3M respirators attenuate speech in decibels The outcome measures are as follows: 1. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
FFP3 Mask
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
23 Jul 2022to 31 Dec 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Nazia Munir, FRCS ORL-HNS contact

07970921448

nazir.munir@liverpoolft.nhs.uk

Todd Kanzara, FRCS ORL-HNS contact

07796945100

todd.kanzara@nhs.net

About this study

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

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

The outcome measures are as follows:

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

Being tested
FFP3 Mask
Keywords
FFP3M respirators, eustachian tube dysfunction, hearing loss, audiometry, tympanometry
Medical subject headings
Hearing Disorders, Nasal Obstruction, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FFP3 MaskOther

    Participans will wear FFP3 respirators during the study.

Study groups in NCT05222230
Study groupRoleWhat they receive
FFP3 RespiratorExperimentalParticipants will wear FFP3 respirators during the study.
Receives: Other: FFP3 Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in baseline pure tone audiometry post intervention.

    We will measure changes in baseline pure tone audiometry post FFP3 respirator usage..

    Measured: 48 hours

  2. Measurement of speech attenuation in decibels.

    We will measure speech attenuation in decibels when participants are wearing FFP3 respirators

    Measured: 1 hours

  3. Changes in baseline tympanometry post intervention

    We will measure changes in baseline tympanometry post FFP3 respirator usage.

    Measured: 48 hours

Secondary outcomes (2)

  1. 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.

    Measured: 48 hours

  2. 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.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start23 Jul 2022 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective open label basic science study.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05222230
Sponsor's protocol ID
SP0620
Acronym
FFP3-RAE
Status last verified
Oct 2021
First submitted
20 Sep 2021
Last updated
31 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No data will be shared with other researchers

Publications

  • 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.

    PubMed 33138498

  • 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.

    PubMed 33389012

  • 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.

    PubMed 32641175

  • 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.

    PubMed 19793277

  • 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.

    PubMed 22374681

Questions about this trial

What is this clinical trial studying?

A study testing FFP3 Mask in people with Eustachian Tube Dysfunction and Hearing Disorders, run by Liverpool University Hospitals NHS Foundation Trust.

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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nazia Munir, FRCS ORL-HNS (07970921448, nazir.munir@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in baseline pure tone audiometry post intervention. (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05222230, which also lists 5 linked publications.

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 31 May 2022.

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