FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing (NCT05222230) | Clinical Trial Compass
UnknownNot Applicable
FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing
12 participantsStarted 2022-07-23
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in baseline pure tone audiometry post intervention.
Timeframe: 48 hours
2
Measurement of speech attenuation in decibels.
Timeframe: 1 hours
3
Changes in baseline tympanometry post intervention
Timeframe: 48 hours
Trial details
NCT IDNCT05222230
SponsorLiverpool University Hospitals NHS Foundation Trust