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

Noise-induced Hearing Loss and Tinnitus Clinical Trial

— gildeaf1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916305
• Other study ID #: Gilbert deafness 1
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: April 4, 2016
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: April 2016
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise-induced Hearing Loss and Tinnitus
• Tinnitus

Intervention

Other:
• Modified Audio video
An audio video modified to mimic noise induced hearing loss after one night at a loud club
• Unmodified audio video
An audio video with unaltered music

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University of Cambridge, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)	Weekly average over the previous month	1 months	No
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	1 months	No