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TUNE! Teaching the UK About Noise Exposure: A Pilot Study

Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00916305
Acronym
gildeaf1
Enrollment
65
Registered
2009-06-09
Start date
2009-07-31
Completion date
2009-11-30
Last updated
2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noise-induced Hearing Loss and Tinnitus

Keywords

deafness noise tinnitus hearingloss

Brief summary

In 1986 The Medical Research Council estimated that 4 million UK adolescents were at risk of hearing damage from over-exposure to loud music from personal audio players (PAPs), gigs, clubs, pubs and festivals. Since that time social noise exposure is estimated to have tripled to 19% of young people. The European Commission commissioned a report that estimated 5-10% of personal audio player users are risking permanent hearing loss and tinnitus by listening to music at high volumes for more than 1 hour a day for 5 years or more. Up to 246 million PAPs were sold in Europe in 2008, and 200 million mobile phones, many of which now have built-in audio players. Nevertheless, a recent survey showed that only 8% of young people identify hearing loss as a health problem. The Royal National Institute for the Deaf (RNID) undertook two surveys of young people in the UK to analyse listening behaviours as part of their Don't Lose the Music campaign. As a consequence they offer listening advice given by flyers at events and online at the dedicated website. There have been no studies to confirm if such advice is effective in reducing noise exposure. Aim: This study will pilot a methodology for a randomised controlled trial to test the effectiveness of a publically-available online video in changing the listening habits of young music lovers i.e. reduce the volume and number of hours of exposure. Hypothesis: A video and adapted sound track demonstrating the experience of noise-induced hearing loss and tinnitus accessed online will change the listening habits of 18-25 year-olds.

Detailed description

Participants aged 18-25 years will be recruited by approaching staff at the LSHTM for recommendations of offspring or friends. Staff will be given information about the study and asked to provide an email address if the recruits are willing. After obtaining informed consent online, participants will be randomized to active intervention i.e. an audio video demonstrating * Normal hearing * Temporary hearing damage after one night at a loud club * Noise-induced hearing loss after repeated exposure (e.g. repeated clubbing for several months) * Tinnitus related to noise exposure Controls will watch the same video with an unaltered soundtrack. Baseline data on listening habits and volumes will be collected prior to the intervention and again at 2 and 4 weeks. All data will be collected using an online system (survey monkey). At no point will researchers meet participants who will also not be known to each other. Compliance will be assessed as participants will have to give a comment at the end of listening to the intervention. Primary outcome: reduction is the proportion of time young people spend listening to music at a dangerous level i.e. equivalent to \>80dB for 8 hours per day for 5 days a week

Interventions

OTHERModified Audio video

An audio video modified to mimic noise induced hearing loss after one night at a loud club

OTHERUnmodified audio video

An audio video with unaltered music

Sponsors

University of Cambridge
CollaboratorOTHER
University of Liverpool
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* between 18 and 25 years of age * used a portable listening device this year * normal hearing * no family history of hearing loss starting before 60 years of age

Exclusion criteria

* recurrent or recent hearing loss, tinnitus or ear disease * hearing loss beginning before 60 years of age in an immediate member of family

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)1 monthsWeekly average over the previous month

Secondary

MeasureTime frameDescription
Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB1 monthsDaily average over the previous month

Countries

United Kingdom

Participant flow

Pre-assignment details

264 assessed for eligibility: 9 excluded 190 did not take initial survey - no reasons given

Participants by arm

ArmCount
Modified Audio Video
Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club
28
Unmodified Audio Video
Participants will listen to the same music as the other arm, but only the track with unaltered music. Unmodified audio video: An audio video with unaltered music
37
Total65

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2127
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicModified Audio VideoUnmodified Audio VideoTotal
Age, Customized
18-25 years
28 participants37 participants65 participants
Sex/Gender, Customized
Male/Female
28 Participants37 Participants65 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)

Weekly average over the previous month

Time frame: 1 months

ArmMeasureGroupValue (MEAN)Dispersion
Modified Audio VideoReduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)Baseline71 Decibels per weekStandard Deviation 36
Modified Audio VideoReduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)At 1 month84 Decibels per weekStandard Deviation 40
Unmodified Audio VideoReduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)Baseline87 Decibels per weekStandard Deviation 16
Unmodified Audio VideoReduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)At 1 month79 Decibels per weekStandard Deviation 14
Secondary

Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB

Daily average over the previous month

Time frame: 1 months

ArmMeasureGroupValue (MEAN)Dispersion
Modified Audio VideoReduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dBBaseline28 Decibels per dayStandard Deviation 31
Modified Audio VideoReduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dBAt 1 month32 Decibels per dayStandard Deviation 33
Unmodified Audio VideoReduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dBBaseline58 Decibels per dayStandard Deviation 26
Unmodified Audio VideoReduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dBAt 1 month46 Decibels per dayStandard Deviation 15

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026