NCT01187251

Brief Summary

The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
Last Updated

August 24, 2010

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

August 23, 2010

Last Update Submit

August 23, 2010

Conditions

Tinnitus

Keywords

tinnitusmp3 playersnoise induced hearing losshigh frequencies audiometryacoustic otoemissions

Study Arms (2)

Group 1 - mp3 users

Subjects who have been using mp3 players for at least 1 hour per day for at least 1 year

Group 2 - mp3 non-users

Subjects who does not listen regularly to mp3 music

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

teenagers and young adults (15 to 30 years old)

You may qualify if:

  • to 30 years old
  • A-n tympanogram

You may not qualify if:

  • muscular tinnitus
  • vascular tinnitus
  • somatosensorial tinnitus
  • concomitant TMJ disorders
  • external and middle ear diseases
  • professional or recreative exposure to other noise sources other than mp3 players

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

caculdade de Medicina de Valença

Valença, Rio de Janeiro, 27600-000, Brazil

Location

OTOSUL,Otorrinolaringologia Sul-Fluminense

Volta Redonda, Rio de Janeiro, 27255-650, Brazil

Location

MeSH Terms

Conditions

TinnitusHearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, SensorineuralHearing Loss

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 24, 2010

Record last verified: 2010-02

Locations

BR(2)