Incidence of Tinnitus Amongst Teenagers and Young Adults... | NCT01187251

Studies
Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users

NCT01187251

Sponsor

Faculdade de Medicina de Valenca

Status

Completed

Last Update Posted

Aug 24, 2010Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Tinnitus

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 23, 2010

First Submission Date that Met QC Criteria

Aug 23, 2010

First Posted Date

Aug 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2010

Last Update Posted Date

Aug 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

15 to 30 years old
A-n tympanogram

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

teenagers and young adults (15 to 30 years old)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
caculdade de Medicina de Valença		Valença	Rio de Janeiro	27600-000	Brazil
OTOSUL,Otorrinolaringologia Sul-Fluminense

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus
D006317	Hearing Loss, Noise-Induced

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided