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

Primary Purpose

Noise-induced Hearing Loss and Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Modified Audio video
Unmodified audio video
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Noise-induced Hearing Loss and Tinnitus focused on measuring deafness noise tinnitus hearingloss

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • London School of Hygiene and Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Audio video

Unmodified Audio video

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
Weekly average over the previous month

Secondary 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
Daily average over the previous month

Full Information

First Posted
June 5, 2009
Last Updated
April 4, 2016
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Cambridge, University of Liverpool
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1. Study Identification

Unique Protocol Identification Number
NCT00916305
Brief Title
TUNE! Teaching the UK About Noise Exposure: A Pilot Study
Acronym
gildeaf1
Official Title
Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Cambridge, University of Liverpool

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise-induced Hearing Loss and Tinnitus
Keywords
deafness noise tinnitus hearingloss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Audio video
Arm Type
Experimental
Arm Description
Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
Arm Title
Unmodified Audio video
Arm Type
Active Comparator
Arm Description
Participants will listen to the same music as the other arm, but only the track with unaltered music.
Intervention Type
Other
Intervention Name(s)
Modified Audio video
Intervention Description
An audio video modified to mimic noise induced hearing loss after one night at a loud club
Intervention Type
Other
Intervention Name(s)
Unmodified audio video
Intervention Description
An audio video with unaltered music
Primary Outcome Measure Information:
Title
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
Description
Weekly average over the previous month
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB
Description
Daily average over the previous month
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Smith, MB ChB
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Director
Facility Information:
Facility Name
London School of Hygiene and Tropical Medicine
City
London
ZIP/Postal Code
Wc1E 7HT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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