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 |
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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 |
|---|---|---|
 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 | |
|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
[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 | ||
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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 | ||
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[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 |