Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-01-01 @ 1:32 AM
Study NCT ID:
NCT00916305
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TUNE! Teaching the UK About Noise Exposure: A Pilot Study
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
Study Overview
Official Title:
Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
gildeaf1
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: