NCT01132092

Brief Summary

There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

First QC Date

May 26, 2010

Last Update Submit

May 26, 2010

Conditions

Keywords

Evoked Potentials, Adult, Hearing Loss

Study Arms (5)

Normal hearing (experimental 1)

76 Normal hearing subjects, male and female, adults, , evaluated by new device

Normal hearing (experimental 2)

15 Normal hearing subjects, male and female, adults, , evaluated by new device

Hearing loss (experimental 3)

15 hearing loss subjects, male and female, adults, evaluated by new device

Gold standard 1

15 Normal hearing subjects, male and female, adults, evaluated by gold standard device

Gold Standard 2

15 hearing loss subjects, male and female, adults, evaluated by gold standard device

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adults Normal hearing subjects and hearing loss Subjects

You may qualify if:

  • hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB.
  • The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual de Ciências da Saúde de Alagoas

Maceió, Alagoas, 57010-300, Brazil

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations