CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Session One Test Battery +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03878875
NCT03878875N/ACompleted

Does Sound Conditioning Protect Against Temporary Hearing Damage

Imperial College Healthcare NHS Trust·observational·Posted Mar 18, 2019·Updated Dec 12, 2024

In Brief

An observational study evaluating Session One Test Battery, Session Two Test Battery, and 1 other intervention for Hearing Loss, Noise-Induced. Completed, enrolled 32 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 18, 2019
Enrollment StartJan 1, 2020
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.3 years ago

Interventions

Session One Test Batteryother

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 Batteryother

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 Batteryother

1 week later (recovery): Repeat test battery.