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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Noise-induced Hearing Loss and Tinnitus
Interventions Other: Modified Audio video
Other: Unmodified audio video
Enrollment 65
Recruitment Details  
Pre-assignment Details 264 assessed for eligibility: 9 excluded 190 did not take initial survey - no reasons given
Arm/Group Title Modified Audio Video Unmodified Audio Video
Hide Arm/Group Description

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

Modified Audio video: 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.

Unmodified audio video: An audio video with unaltered music
Period Title: Overall Study
Started 28 37
Completed 7 9
Not Completed 21 28
Reason Not Completed
Lost to Follow-up             21             27
Withdrawal by Subject             0             1
Arm/Group Title Modified Audio Video Unmodified Audio Video Total
Hide Arm/Group Description

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

Modified Audio video: 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.

Unmodified audio video: An audio video with unaltered music

 Total of all reporting groups
Overall Number of Baseline Participants 28 37 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18-25 years Number Analyzed 28 participants 37 participants 65 participants
28 37 65
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Male/Female Number Analyzed 28 participants 37 participants 65 participants
28 37 65
[1]
Measure Description: Per-arm data are not available. A total of 51 (78.5%) participants were female and a total of 14 (21.5%) participants were Male
1.Primary Outcome
Title Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
Hide Description Weekly average over the previous month
Time Frame 1 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Audio Video Unmodified Audio Video
Hide Arm/Group Description:

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

Modified Audio video: 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.

Unmodified audio video: An audio video with unaltered music
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: Decibels per week
Baseline 71  (36) 87  (16)
At 1 month 84  (40) 79  (14)
2.Secondary Outcome
Title Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB
Hide Description Daily average over the previous month
Time Frame 1 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Audio Video Unmodified Audio Video
Hide Arm/Group Description:

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

Modified Audio video: 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.

Unmodified audio video: An audio video with unaltered music
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: Decibels per day
Baseline 28  (31) 58  (26)
At 1 month 32  (33) 46  (15)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not monitored in this study
 
Arm/Group Title Modified Audio Video Unmodified Audio Video
Hide Arm/Group Description

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

Modified Audio video: 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.

Unmodified audio video: An audio video with unaltered music
All-Cause Mortality
Modified Audio Video Unmodified Audio Video
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Modified Audio Video Unmodified Audio Video
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modified Audio Video Unmodified Audio Video
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clare Gilbert
Organization: London School of Hygiene & Tropical Medicine
Phone: +44 207 958 8332
EMail: clare.gilbert@lshtm.ac.uk
Layout table for additonal information
Responsible Party: Clare Gilbert, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00916305    
Other Study ID Numbers: Gilbert deafness 1
First Submitted: June 5, 2009
First Posted: June 9, 2009
Results First Submitted: April 4, 2016
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016