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TUNE! Teaching the UK About Noise Exposure: A Pilot Study (gildeaf1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00916305
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborators:
University of Cambridge
University of Liverpool
Information provided by (Responsible Party):
Clare Gilbert, London School of Hygiene and Tropical Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Noise-induced Hearing Loss and Tinnitus Other: Modified Audio video Other: Unmodified audio video Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus
Study Start Date : July 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Audio video
Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
 Other: Modified Audio video
An audio video modified to mimic noise induced hearing loss after one night at a loud club
Active Comparator: Unmodified Audio video
Participants will listen to the same music as the other arm, but only the track with unaltered music.
 Other: Unmodified audio video
An audio video with unaltered music


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD) [ Time Frame: 1 months ]
    Weekly average over the previous month


Secondary Outcome Measures :
  1. Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB [ Time Frame: 1 months ]
    Daily average over the previous month


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916305


Locations
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United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, Wc1E 7HT
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Cambridge
University of Liverpool
Investigators
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Study Director: Andrew Smith, MB ChB London School of Hygiene and Tropical Medicine
More Information
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Responsible Party: Clare Gilbert, Professor of International Eye Health, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00916305    
Other Study ID Numbers: Gilbert deafness 1
First Posted: June 9, 2009    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016
Last Verified: April 2016
Keywords provided by Clare Gilbert, London School of Hygiene and Tropical Medicine:
deafness noise tinnitus hearingloss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Tinnitus
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural