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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00593788
Other study ID # 113 / 02
Secondary ID 113/02 de 03/13/
Status Completed
Phase N/A
First received January 3, 2008
Last updated January 14, 2008
Start date March 2003
Est. completion date June 2004

Study information

Verified date January 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

The aim of this study was to establish parameters for the Gaps-in-Noise test in normal-hearing young adults. One hundred subjects (50 males and 50 females) received an audiological evaluation to rule out hearing loss and auditory processing disorder. The Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was 4.19 msec. A psychometric function by gap duration was constructed, revealing that the percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec, 10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for gap durations of 5 msec or longer. The results suggest that the data obtained can be applied as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test proved to be consistent with low variability.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 31 Years
Eligibility Inclusion Criteria:

Subject inclusion criteria were:

- all of the subjects have to have auditory thresholds lower than 20 dB HL at all of the frequencies evaluated (octave frequencies between 0.25 to 8 kHz), bilaterally;

- type A tympanometric curves with presented ipsilateral and contralateral acoustic reflexes;

- 95% or higher correct responses for each ear in the dichotic digit test.

Subject inclusion criteria also included negative histories for audiologic, otologic, head trauma, and neurologic involvement.

Exclusion Criteria:

- Hearing loss;

- Auditory processing disorder;

- Histories of audiologic, otologic, head trauma, and neurologic involvement.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary gap detection test half hour No
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