Adults 18 to 35, any sex, with Hearing Loss, Noise-Induced. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PTA (EF)Primary· 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).
Session 1
Group
Value
95% CI
High Noise Exposure
7.06
± 8.15
Low Noise Exposure
8.94
± 5.46
Session 2
Group
Value
95% CI
High Noise Exposure
7.94
± 8.35
Low Noise Exposure
12.19
± 6.45
DPOAE (DP)Primary· 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 pa
DP (2-10 kHz), Session 1
Group
Value
95% CI
High Noise Exposure
1.25
± 5.03
Low Noise Exposure
-0.06
± 4.86
DP (2-10 kHz), Session 2
Group
Value
95% CI
High Noise Exposure
1.75
± 5.04
Low Noise Exposure
-0.88
± 4.53
DPOAE (SNR)Primary· 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 pa
SNR (2-10 kHz), Session 1
Group
Value
95% CI
High Noise Exposure
12.94
± 4.33
Low Noise Exposure
11.63
± 4.15
SNR (2-10 kHz), Session 2
Group
Value
95% CI
High Noise Exposure
13.13
± 4.63
Low Noise Exposure
11.19
± 3.85
MEMRPrimary· 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.
Session 1
Group
Value
95% CI
High Noise Exposure
88.91
± 7.41
Low Noise Exposure
88.44
± 8.56
Session 2
Group
Value
95% CI
High Noise Exposure
91.25
± 6.71
Low Noise Exposure
90.31
± 10.20
SiNPrimary· 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.
Session 1
Group
Value
95% CI
High Noise Exposure
2.38
± 2.53
Low Noise Exposure
2.94
± 2.77
Session 2
Group
Value
95% CI
High Noise Exposure
1.38
± 2.73
Low Noise Exposure
2.44
± 2.76
TinnitusPrimary· 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.
Session 1
Group
Value
95% CI
High Noise Exposure
5
Low Noise Exposure
1
Session 2
Group
Value
95% CI
High Noise Exposure
5
Low Noise Exposure
7
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Imperial College Healthcare NHS Trust
Last refreshed: 12 December 2024
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