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The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01132092
First Posted: May 27, 2010
Last Update Posted: May 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade Estadual de Ciências da Saúde de Alagoas
  Purpose
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.

Condition
Normal Hearing (76 Subjects) Subjects With Hearing Loss (15 Subjects)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Ciências da Saúde de Alagoas:

Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults Normal hearing subjects and hearing loss Subjects
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132092


Locations
Brazil
Universidade Estadual de Ciências da Saúde de Alagoas
Maceió, Alagoas, Brazil, 57010-300
Sponsors and Collaborators
Universidade Estadual de Ciências da Saúde de Alagoas
  More Information

ClinicalTrials.gov Identifier: NCT01132092     History of Changes
Other Study ID Numbers: UNCISAL-IS-001
First Submitted: May 26, 2010
First Posted: May 27, 2010
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Universidade Estadual de Ciências da Saúde de Alagoas:
Evoked Potentials, Adult, Hearing Loss

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms