Hearing Loss, Noise-InducedNCT03878875
Does Sound Conditioning Protect Against Temporary Hearing Damage
An observational study of Hearing Loss, Noise-Induced, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This research project will contribute to the research surrounding the effect on the ear after noise exposure. This ever-growing field of research has never been more applicable than now with the increase of recreational noise exposure. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Noise-Induced
- What is being tested?
- Session One Test Battery, Session Two Test Battery and Session Three Test Battery
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 1 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 32 Normal Hearing, Healthy 18-35-year-olds.
Who may be able to join
- 18-35 years old (as age can affect cochlea hair cell function)
- Healthy participants with no significant medical conditions
- 0.25 Hz to 8 kHz PTA <= 20 dB HL indicating normal hearing
- Otoscopy to ensure no otological abnormalities
- No exposure to abnormally loud sounds in the past 24 hours
- Full capacity to consent
- Able to speak fluent English so information sheets, consent forms and instructions are fully understood
- Previous intention to attend a loud noise event during the course of the study, without the use of hearing protection
Who cannot join
- No permanent tinnitus or hyperacusis (sensitivity to loud sounds) which would mean participants are unable to undertake all testing and a high exposure event
- Any contraindications for testing i.e. excessive wax, infections
- One or more frequencies 0.25 Hz to 8 kHz > 20 dB HL in either ear
- Not involved in current research or have recently been involved in any research prior to recruitment
Trial locations and contacts
1 site in 1 country.
About this study
This research project will contribute to the research surrounding the effect on the ear after noise exposure. This ever-growing field of research has never been more applicable than now with the increase of recreational noise exposure. Noise is the leading cause of preventable hearing loss and excessive occupational noise along with recreational noise exposure can cause a devastating disability. The World Health Organisation (WHO) estimates 1.1 billion young people could be at risk of hearing loss due to unsafe listening practices.
One of the mechanisms that could increase the resistance against noise induced hearing loss is 'sound conditioning'. Animal studies have found that prior exposure to low level noise over a period of a few weeks can 'condition' the ear. This conditioning then reduces the susceptibility to high level exposure i.e. strengthening the ear. In this study, the investigators aim to determine whether previous exposure to loud noise can condition the human ear, reducing the temporary hearing loss and temporary tinnitus ("ringing in the ear") that sometimes occurs after attending a loud nightclub or live music event.
There are many implications of this research. The long-term effects of non-damaging lifetime noise exposures are unclear. Principally, this research will allow better understanding about noise susceptibility and resistance, allowing for appropriate interventions, thus improving care. For instance, an individual more susceptible due to low prior exposure can be advised of risks and encouraged to use hearing protection. This thesis will increase the knowledge base surrounding the impacts of noise on hearing and educate others in understanding these.
Read the detailed description
Objective: This study explored if sound conditioning (recent noise exposure) protects individuals against temporary hearing damage.
Design: Participants attended two sessions in this between-group repeated measures trial; the first included a noise exposure structured interview. Five dependent variables were measured before and after attending a loud event: EFA, DPOAE, MEMR, QuickSIN and Tinnitus. It was hypothesised those with high recent noise exposure, Group 1 (noise unit > 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.
Sample: Thirty-two normal hearing participants with a mean age of 26 ± 3.3 years (16 males, 16 females).
- Conditions
- Hearing Loss, Noise-Induced
- Being tested
- Session One Test Battery, Session Two Test Battery, Session Three Test Battery
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session One Test BatteryDiagnostic test
Prior to noise exposure:
Test battery - High-frequency audiometry, Distortion Product Otoacoustic Emissions, Middle Ear Muscle Reflex, Speech-in-Noise test (Around 35 minutes with breaks if required)
- Extended Frequency Audiometry (~ 8 min), 0.25-16 kHz: Participants will be asked to press the button when they hear a sound through the headphones in a soundproof booth.
- DPOAE (~ 5 min), 0.5-10 kHz: A small tip will be placed in participants' ear and they will hear a sound. The tip measures a response from hair cells in the cochlea and they will not need to do anything.
- MEMR (~ 8 min), 4 kHz: A small tip placed in both ears and again a sound heard, however, this sound will gradually get louder until an involuntary muscle reflex is noted.
- Speech-in-Noise Test (~ 5 min): Participants asked to repeat back a list of words as best as they can.
- Tinnitus: Participants were also asked if they experience any tinnitus i.e. bilateral, lasting > 5 minutes. This was reported as Y/N.
Session Two Test BatteryDiagnostic test
Exposure at single loud music event (Important that this is part of participants' normal recreational routine, and specifically require that attendance is not prompted by participation in this study): Participants to use sound level meter provided from the Audiology Department at Charing Cross Hospital or sound level meter applications to measure sound levels inside the loud event.
Morning after exposure: Repeat test battery from session one - Ideally as soon as event is over.
Session Three Test BatteryDiagnostic test
1 week later (recovery): Repeat test battery.
| Study group | Role | What they receive |
|---|---|---|
| High Noise Exposure | One group (16, 8f:8m) with previous exposure i.e. nightclubs ++ Receives: Diagnostic Test: Session One Test Battery; Diagnostic Test: Session Two Test Battery; Diagnostic Test: Session Three Test Battery | |
| Low Noise Exposure | Group (16, 8f:8m) with less exposure measured through NESI Receives: Diagnostic Test: Session One Test Battery; Diagnostic Test: Session Two Test Battery; Diagnostic Test: Session Three Test Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTA (EF)
Extended Frequency (EF) PTA with results measured in dBHL where higher values mean worse hearing thresholds.
Hearing thresholds were measured in the two sessions (unfortunately session three was not completed). A single dB HL value was calculated by averaging results across participants in each session (Extended frequency audiometry (EFA) comprised of averaging 2-16 kHz).
Measured: 35 minutes per session
DPOAE (DP)
Distortion Product Otoacousic Emissions (DPOAE), DPOAEs were recorded bilaterally (at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 kHz) using the Otometrics Madsen Capella2. A daily check was performed in a 2 cc test cavity and tester's own ear to verify suitable recordings and ensure the probe was providing true responses. Measure results in the two sessions (unfortunately session three was not completed). DPOAE measurements were separated into distortion product (DP - dB SPL) and signal-to-noise ratio (SNR - dB) and averaged from 2-10 kHz. A single value was calculated by averaging results across participants in each session.
Measured: 35 minutes per session
DPOAE (SNR)
Distortion Product Otoacousic Emissions (DPOAE), DPOAEs were recorded bilaterally (at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 kHz) using the Otometrics Madsen Capella2. A daily check was performed in a 2 cc test cavity and tester's own ear to verify suitable recordings and ensure the probe was providing true responses. Measure results in the two sessions (unfortunately session three was not completed). DPOAE measurements were separated into distortion product (DP - dB SPL) and signal-to-noise ratio (SNR - dB) and averaged from 2-10 kHz. A single value was calculated by averaging results across participants in each session.
Measured: 35 minutes per session
MEMR
Middle Ear Muscle Reflex (MEMR) measured at 4 kHz bilaterally in dB SPL. A reflex was defined as > 0.02 ml compliance with appropriate morphology free from artefacts. Measure if MEMR is present/raised in the sessions. Averages between ears were also calculated for MEMR to give one result per participant for each session. A single value was then calculated by averaging results across participants in each session.
Measured: 35 minutes per session
SiN
Speech in Noise (SiN) Test, Score. The sound field JBL Control One speakers and the Kamplex KM4 sound level meter (SLM) were calibrated via Guymark. Daily checks were conducted to assess speaker reliability when administering QuickSIN (Etymotic Research, 2001) with the signal and noise presented from the same speaker at 0° azimuths. The SLM confirmed speaker calibration and sound levels presented were within tolerances. Measure SiN in the sessions and a single value was calculated by averaging results across participants in each session.
Measured: 35 minutes per session
Tinnitus
Participants were also asked if they experience any tinnitus i.e. bilateral, lasting > 5 minutes. This was reported as Y/N. An increase in underlying tinnitus, no change in underlying tinnitus and newly reported tinnitus was counted for each group in the second session. We aimed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure. Session 1: existing underlying tinnitus reported. Session 2: Newly reported tinnitus and increase in underlying tinnitus.
Measured: 35 minutes per session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, Noise-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Frost, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878875
- Sponsor's protocol ID
- 19CX4979
- Status last verified
- Dec 2024
- First submitted
- 11 Mar 2019
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sound Conditioning Protect Against Temporary Hearing Damage
- ClinicalTrials.gov ID
- NCT03878875
- Acronym / sponsor ID
- 19CX4979
- Conditions
- Hearing Loss, Noise-Induced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project will contribute to the research surrounding the effect on the ear after noise exposure. This ever-growing field of research has never been more applicable than now with the increase of recreational noise exposure. Noise is the leading cause of preventable hearing loss and excessive occupational noise along with recreational noise exposure can cause a devastating disability. The World Health Organisation (WHO) estimates 1.1 billion young people could be at risk of hearing loss due to unsafe listening practices.
One of the mechanisms that could increase the resistance against noise induced hearing loss is 'sound conditioning'. Animal studies have found that prior exposure to low level noise over a period of a few weeks can 'condition' the ear. This conditioning then reduces the susceptibility to high level exposure i.e. strengthening the ear. In this study, the investigators aim to determine whether previous exposure to loud noise can condition the human ear, reducing the temporary hearing loss and temporary tinnitus ("ringing in the ear") that sometimes occurs after attending a loud nightclub or live music event.
There are many implications of this research. The long-term effects of non-damaging lifetime noise exposures are unclear. Principally, this research will allow better understanding about noise susceptibility and resistance, allowing for appropriate interventions, thus improving care. For instance, an individual more susceptible due to low prior exposure can be advised of risks and encouraged to use hearing protection. This thesis will increase the knowledge base surrounding the impacts of noise on hearing and educate others in understanding these.
Detailed description
Objective: This study explored if sound conditioning (recent noise exposure) protects individuals against temporary hearing damage.
Design: Participants attended two sessions in this between-group repeated measures trial; the first included a noise exposure structured interview. Five dependent variables were measured before and after attending a loud event: EFA, DPOAE, MEMR, QuickSIN and Tinnitus. It was hypothesised those with high recent noise exposure, Group 1 (noise unit > 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.
Sample: Thirty-two normal hearing participants with a mean age of 26 ± 3.3 years (16 males, 16 females).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Noise Exposure | – | Diagnostic Test: Session One Test Battery, Diagnostic Test: Session Two Test Battery, Diagnostic Test: Session Three Test BatteryOne group (16, 8f:8m) with previous exposure i.e. nightclubs ++ |
| Low Noise Exposure | – | Diagnostic Test: Session One Test Battery, Diagnostic Test: Session Two Test Battery, Diagnostic Test: Session Three Test BatteryGroup (16, 8f:8m) with less exposure measured through NESI |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 32 Normal Hearing, Healthy 18-35-year-olds.
Key inclusion criteria (8 listed)
- 18-35 years old (as age can affect cochlea hair cell function)
- Healthy participants with no significant medical conditions
- 0.25 Hz to 8 kHz PTA <= 20 dB HL indicating normal hearing
- Otoscopy to ensure no otological abnormalities
- No exposure to abnormally loud sounds in the past 24 hours
Key exclusion criteria (4 listed)
- No permanent tinnitus or hyperacusis (sensitivity to loud sounds) which would mean participants are unable to undertake all testing and a high exposure event
- Any contraindications for testing i.e. excessive wax, infections
- One or more frequencies 0.25 Hz to 8 kHz > 20 dB HL in either ear
- Not involved in current research or have recently been involved in any research prior to recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Session One Test BatteryPrior to noise exposure: Test battery - High-frequency audiometry, Distortion Product Otoacoustic Emissions, Middle Ear Muscle Reflex, Speech-in-Noise test (Around 35 minutes with breaks if required) * Extended Frequency Audiometry (~ 8 min), 0.25-16 kHz: Participants will be asked to press the button when they hear a sound through the headphones in a soundproof booth. * DPOAE (~ 5 min), 0.5-10 kHz: A small tip will be placed in participants' ear and they will hear a sound. The tip measures a response from hair cells in the cochlea and they will not need to do anything. * MEMR (~ 8 min), 4 kHz: A small tip placed in both ears and again a sound heard, however, this sound will gradually get louder until an involuntary muscle reflex is noted. * Speech-in-Noise Test (~ 5 min): Participants asked to repeat back a list of words as best as they can. * Tinnitus: Participants were also asked if they experience any tinnitus i.e. bilateral, lasting > 5 minutes. This was reported as Y/N. | Diagnostic test | High Noise Exposure, Low Noise Exposure |
| Session Two Test BatteryExposure at single loud music event (Important that this is part of participants' normal recreational routine, and specifically require that attendance is not prompted by participation in this study): Participants to use sound level meter provided from the Audiology Department at Charing Cross Hospital or sound level meter applications to measure sound levels inside the loud event. Morning after exposure: Repeat test battery from session one - Ideally as soon as event is over. | Diagnostic test | High Noise Exposure, Low Noise Exposure |
| Session Three Test Battery1 week later (recovery): Repeat test battery. | Diagnostic test | High Noise Exposure, Low Noise Exposure |
Primary outcome
PTA (EF)
Time frame: 35 minutes per session
Extended Frequency (EF) PTA with results measured in dBHL where higher values mean worse hearing thresholds. Hearing thresholds were measured in the two sessions (unfortunately session three was not completed). A single dB HL value was calculated by averaging results across participants in each session (Extended frequency audiometry (EFA) comprised of averaging 2-16 kHz).
DPOAE (DP)
Time frame: 35 minutes per session
Distortion Product Otoacousic Emissions (DPOAE), DPOAEs were recorded bilaterally (at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 kHz) using the Otometrics Madsen Capella2. A daily check was performed in a 2 cc test cavity and tester's own ear to verify suitable recordings and ensure the probe was providing true responses. Measure results in the two sessions (unfortunately session three was not completed). DPOAE measurements were separated into distortion product (DP - dB SPL) and signal-to-noise ratio (SNR - dB) and averaged from 2-10 kHz. A single value was calculated by averaging results across participants in each session.
DPOAE (SNR)
Time frame: 35 minutes per session
Distortion Product Otoacousic Emissions (DPOAE), DPOAEs were recorded bilaterally (at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 kHz) using the Otometrics Madsen Capella2. A daily check was performed in a 2 cc test cavity and tester's own ear to verify suitable recordings and ensure the probe was providing true responses. Measure results in the two sessions (unfortunately session three was not completed). DPOAE measurements were separated into distortion product (DP - dB SPL) and signal-to-noise ratio (SNR - dB) and averaged from 2-10 kHz. A single value was calculated by averaging results across participants in each session.
MEMR
Time frame: 35 minutes per session
Middle Ear Muscle Reflex (MEMR) measured at 4 kHz bilaterally in dB SPL. A reflex was defined as > 0.02 ml compliance with appropriate morphology free from artefacts. Measure if MEMR is present/raised in the sessions. Averages between ears were also calculated for MEMR to give one result per participant for each session. A single value was then calculated by averaging results across participants in each session.
SiN
Time frame: 35 minutes per session
Speech in Noise (SiN) Test, Score. The sound field JBL Control One speakers and the Kamplex KM4 sound level meter (SLM) were calibrated via Guymark. Daily checks were conducted to assess speaker reliability when administering QuickSIN (Etymotic Research, 2001) with the signal and noise presented from the same speaker at 0° azimuths. The SLM confirmed speaker calibration and sound levels presented were within tolerances. Measure SiN in the sessions and a single value was calculated by averaging results across participants in each session.
Tinnitus
Time frame: 35 minutes per session
Participants were also asked if they experience any tinnitus i.e. bilateral, lasting > 5 minutes. This was reported as Y/N. An increase in underlying tinnitus, no change in underlying tinnitus and newly reported tinnitus was counted for each group in the second session. We aimed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure. Session 1: existing underlying tinnitus reported. Session 2: Newly reported tinnitus and increase in underlying tinnitus.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Frost principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Noise-Induced, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTA (EF) (time frame: 35 minutes per session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2024.