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

NCT ID: NCT00916305

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-11-30

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

Conditions

Noise-induced Hearing Loss and Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Modified Audio video

Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club

Group Type: EXPERIMENTAL

Modified Audio video

Intervention Type: OTHER

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

Unmodified Audio video

Participants will listen to the same music as the other arm, but only the track with unaltered music.

Group Type: ACTIVE_COMPARATOR

Unmodified audio video

Intervention Type: OTHER

An audio video with unaltered music

Interventions

Modified Audio video

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

Intervention Type: OTHER

Unmodified audio video

An audio video with unaltered music

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Clare Gilbert

Professor of International Eye Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Smith, MB ChB

Role: STUDY_DIRECTOR

London School of Hygiene and Tropical Medicine

Locations

London School of Hygiene and Tropical Medicine

London, London, United Kingdom

Countries

United Kingdom

Other Identifiers

Gilbert deafness 1

Identifier Type: -

Identifier Source: org_study_id