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Earplugs at music festivals


- candidate number22836
- NTR NumberNTR5401
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2015
- Secondary IDs15-384/C METC
- Public TitleEarplugs at music festivals
- Scientific TitlePrevention of hearing loss at music festivals
- ACRONYM
- hypothesisWearing earplugs at festivals will prevent hearing loss. This can be identified by the presence/absence of a transient threshold shift in a audiogram of a non earplug user in comparison to an earplug user.
- Healt Condition(s) or Problem(s) studiedHearing loss,
- Inclusion criteria18 years or older
no current earproblems: perforation of the eardrum, infection, otorrhoe,
No hearing aid or cochleair implant
Surgery of either ear in the past, except for tubes in the eardrum
- Exclusion criteria<18 years old
currently a perforation of the eardrum, infection, otorrhoe, tube in situ
Wearing a hearing aid or cochleair implant
Surgery of either ear in the past, except for tubes in the eardrum
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-sep-2015
- planned closingdate
- Target number of participants24
- Interventionswearing earplugs to the festival for at least 4,5 hours
- Primary outcomeaudiometry: presence of a transient threshold shift (TTS)
- Secondary outcomeDPOAE: distortion product otoacoustic emisions
Presence of tinnitus by questionnaire
In case of tinnitus: tinnitus pitch and loudness matching
- Timepointsmeasurement before festival = pre
measurement after 4,5 hours of music exposure = post
- Trial web siteN.A.
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. W. Grolman
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W. Grolman
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-sep-2015 - 18-okt-2015


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