Trial Outcomes & Findings for TUNE! Teaching the UK About Noise Exposure: A Pilot Study (NCT NCT00916305)
NCT ID: NCT00916305
Last Updated: 2016-04-05
Results Overview
Weekly average over the previous month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
1 months
Results posted on
2016-04-05
Participant Flow
264 assessed for eligibility: 9 excluded 190 did not take initial survey - no reasons given
Participant milestones
| Measure |
Modified Audio Video
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
|
Unmodified Audio Video
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 Study
STARTED
|
28
|
37
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
21
|
28
|
Reasons for withdrawal
| Measure |
Modified Audio Video
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
|
Unmodified Audio Video
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 Study
Lost to Follow-up
|
21
|
27
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
TUNE! Teaching the UK About Noise Exposure: A Pilot Study
Baseline characteristics by cohort
| Measure |
Modified Audio Video
n=28 Participants
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
|
Unmodified Audio Video
n=37 Participants
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
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-25 years
|
28 participants
n=5 Participants
|
37 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male/Female
|
28 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthsWeekly average over the previous month
Outcome measures
| Measure |
Modified Audio Video
n=7 Participants
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
|
Unmodified Audio Video
n=9 Participants
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
|
|---|---|---|
|
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
Baseline
|
71 Decibels per week
Standard Deviation 36
|
87 Decibels per week
Standard Deviation 16
|
|
Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)
At 1 month
|
84 Decibels per week
Standard Deviation 40
|
79 Decibels per week
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 1 monthsDaily average over the previous month
Outcome measures
| Measure |
Modified Audio Video
n=7 Participants
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
|
Unmodified Audio Video
n=9 Participants
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
|
|---|---|---|
|
Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB
Baseline
|
28 Decibels per day
Standard Deviation 31
|
58 Decibels per day
Standard Deviation 26
|
|
Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB
At 1 month
|
32 Decibels per day
Standard Deviation 33
|
46 Decibels per day
Standard Deviation 15
|
Adverse Events
Modified Audio Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unmodified Audio Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clare Gilbert
London School of Hygiene & Tropical Medicine
Phone: +44 207 958 8332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place