Noise-induced Hearing Loss and Tinnitusgildeaf1NCT00916305
TUNE! Teaching the UK About Noise Exposure: A Pilot Study
A study testing Modified Audio video and Unmodified audio video in people with Noise-induced Hearing Loss and Tinnitus, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise-induced Hearing Loss and Tinnitus
- What is being tested?
- Modified Audio video and Unmodified audio video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- recurrent or recent hearing loss, tinnitus or ear disease
- hearing loss beginning before 60 years of age in an immediate member of family
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene and Tropical Medicine
London, London, Wc1E 7HT
About this study
Official title: Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus
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.
Read the 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
- Being tested
- Modified Audio video, Unmodified audio video
- Keywords
- deafness noise tinnitus hearingloss
- Medical subject headings
- Hearing Loss, Noise-Induced, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Audio videoOther
An audio video modified to mimic noise induced hearing loss after one night at a loud club
Unmodified audio videoOther
An audio video with unaltered music
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Modified Audio video |
| Unmodified Audio video | Active comparator | Participants will listen to the same music as the other arm, but only the track with unaltered music. Receives: Other: Unmodified audio video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
Weekly average over the previous month
Measured: 1 months
Secondary outcomes (1)
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
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Noise-induced Hearing Loss and TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Liverpool
- Responsible party
- Principal investigator, Clare Gilbert, London School of Hygiene and Tropical Medicine
- Investigators
- Andrew Smith, MB ChB, Study director, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916305
- Sponsor's protocol ID
- Gilbert deafness 1
- Acronym
- gildeaf1
- Status last verified
- Apr 2016
- First submitted
- 5 Jun 2009
- Last updated
- 5 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Intervention Among Young People to Prevent Noise-induced Hearing Loss and Tinnitus
- ClinicalTrials.gov ID
- NCT00916305
- Acronym / sponsor ID
- gildeaf1 / Gilbert deafness 1
- Conditions
- Noise-induced Hearing Loss and Tinnitus
- Keywords
- deafness noise tinnitus hearingloss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Liverpool
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Posted 5 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Audio video | Experimental | Other: Modified Audio videoParticipants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club |
| Unmodified Audio video | Active comparator | Other: Unmodified audio videoParticipants will listen to the same music as the other arm, but only the track with unaltered music. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- recurrent or recent hearing loss, tinnitus or ear disease
- hearing loss beginning before 60 years of age in an immediate member of family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Audio videoAn audio video modified to mimic noise induced hearing loss after one night at a loud club | Other | Modified Audio video |
| Unmodified audio videoAn audio video with unaltered music | Other | Unmodified Audio video |
Primary outcome
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
Time frame: 1 months
Weekly average over the previous month
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Noise-induced Hearing Loss and Tinnitus
Active, not recruitingObservational study
Apple Hearing Study
Hearing Loss, Noise-Induced, Hearing Loss
Enrolling by invitationEarly Phase 1
Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Smith, MB ChB study director
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Audio video and Unmodified audio video in people with Noise-induced Hearing Loss and Tinnitus, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD) (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.