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临床试验/NCT00916305
NCT00916305已完成不适用

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

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2009年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •recurrent or recent hearing loss, tinnitus or ear disease
  • •hearing loss beginning before 60 years of age in an immediate member of family

研究组 & 干预措施

Modified Audio video

Experimental

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

干预措施: Modified Audio video (Other)

Unmodified Audio video

Active Comparator

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

干预措施: Unmodified audio video (Other)

结局指标

主要结局

Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)

时间窗: 1 months

Weekly average over the previous month

次要结局

  • Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB(1 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clare Gilbert

Professor of International Eye Health

London School of Hygiene and Tropical Medicine

研究点 (1)

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