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| Name | Class |
|---|---|
| University of Cambridge | OTHER |
| University of Liverpool | OTHER |
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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.
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Audio video | Experimental | Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club |
|
| Unmodified Audio video | Active Comparator | Participants will listen to the same music as the other arm, but only the track with unaltered music. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Audio video | Other | An audio video modified to mimic noise induced hearing loss after one night at a loud club |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD) | Weekly average over the previous month | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Smith, MB ChB | London School of Hygiene and Tropical Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London School of Hygiene and Tropical Medicine | London | London | Wc1E 7HT | United Kingdom |
264 assessed for eligibility: 9 excluded 190 did not take initial survey - no reasons given
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Unmodified Audio Video |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Decibels per day | 1 months |
|
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Adverse events were not monitored in this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clare Gilbert | London School of Hygiene & Tropical Medicine | +44 207 958 8332 | clare.gilbert@lshtm.ac.uk |
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| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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| Unmodified audio video | Other | An audio video with unaltered music |
|
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 |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Per-arm data are not available. A total of 51 (78.5%) participants were female and a total of 14 (21.5%) participants were Male | Number | Participants |
|
|
|
| Primary | Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD) | Weekly average over the previous month | Posted | Mean | Standard Deviation | Decibels per week | 1 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |