TUNE! Teaching the UK About Noise Exposure: A Pilot Study (gildeaf1)
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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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
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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 |
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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
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Name/Title: | Clare Gilbert |
Organization: | London School of Hygiene & Tropical Medicine |
Phone: | +44 207 958 8332 |
EMail: | clare.gilbert@lshtm.ac.uk |
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 |