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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Cambridge
University of Liverpool
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00916305
First received: June 5, 2009
Last updated: July 24, 2009
Last verified: July 2009
  Purpose

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 Intervention
Noise-induced Hearing Loss and Tinnitus
Other: Modified Audio video
Other: Audio video

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • 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: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: July 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Audio video
The active intervention will be an audio video with 3 parts: 1) unaltered music. 2) the same music, but after modification to mimic noise induced hearing loss after one night at a loud club 3) hearing loss after repeated exposure to loud music 4) noise-induced tinnitus
Other: Modified Audio video
The active intervention will be an audio video with 3 parts: 1) unaltered music. 2) the same music, but after modification to mimic noise induced hearing loss after one night at a loud club 3) hearing loss after repeated exposure to loud music 4) noise-induced tinnitus
Other: Audio video
The active intervention will be an audio video with 3 parts: 1) unaltered music. 2) the same music, but after modification to mimic noise induced hearing loss after one night at a loud club 3) hearing loss after repeated exposure to loud music 4) noise-induced tinnitus
Sham Comparator: Control
Participants will listen to the same music as the other arm, but only the track with unaltered music.
Other: Audio video
The active intervention will be an audio video with 3 parts: 1) unaltered music. 2) the same music, but after modification to mimic noise induced hearing loss after one night at a loud club 3) hearing loss after repeated exposure to loud music 4) noise-induced tinnitus

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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916305

Locations
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
Study Director: Andrew Smith, MB ChB London School of Hygiene and Tropical Medicine
  More Information

No publications provided

Responsible Party: Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00916305     History of Changes
Other Study ID Numbers: Gilbert deafness 1
Study First Received: June 5, 2009
Last Updated: July 24, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
deafness noise tinnitus hearingloss

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural

ClinicalTrials.gov processed this record on August 28, 2014