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

NCT05222230 | Unknown DMC

• 1 other identifier: SP0620
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

1. 1.To determine the effect of Filtering Facepiece (FFP3M) respirators on eustachian tube function and hearing
2. 2.To evaluate the extent to which FFP3M respirators attenuate speech in decibels
3. 3.Changes in baseline pure tone audiometry and tympanometry post intervention.
4. 4.SNOT-22 Questionnaires before and after use of respirator
5. 5.ETDQ7 questionnaire
6. 6.Measurement of speech attenuation in decibels.

Conditions

Eustachian Tube Dysfunction; Hearing Disorders; Nasal Obstruction

Keywords

FFP3M respirators; eustachian tube dysfunction; hearing loss; audiometry; tympanometry

Outcome Measures

Primary Outcomes (3)

• Changes in baseline pure tone audiometry post intervention.

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

  48 hours

• Measurement of speech attenuation in decibels.

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

  1 hours

• Changes in baseline tympanometry post intervention

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

  48 hours

Secondary Outcomes (2)

• Eustachian tube function

  48 hours

• Eustachian tube function

  48 hours

Study Arms (1)

FFP3 Respirator

EXPERIMENTAL

Participants will wear FFP3 respirators during the study.

Other: FFP3 Mask

Interventions

FFP3 Mask OTHER

Participans will wear FFP3 respirators during the study.

FFP3 Respirator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Related Publications (5)

• 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.

  PMID: 33138498 BACKGROUND

• 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.

  PMID: 33389012 BACKGROUND

• 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.

  PMID: 32641175 BACKGROUND

• 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.

  PMID: 19793277 BACKGROUND

• 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.

  PMID: 22374681 BACKGROUND

MeSH Terms

Conditions

Hearing Disorders; Nasal Obstruction; Hearing Loss

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Central Study Contacts

Nazia Munir, FRCS ORL-HNS

CONTACT

07970921448; nazir.munir@liverpoolft.nhs.uk

Todd Kanzara, FRCS ORL-HNS

CONTACT

07796945100; todd.kanzara@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective open label basic science study.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: February 3, 2022
• Study Start: July 23, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 31, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share