NCT00593788

Brief 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.

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 Mar 2003

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

Study Start

First participant enrolled

March 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

1.3 years

First QC Date

January 3, 2008

Last Update Submit

January 14, 2008

Conditions

Keywords

GIN testgap detectiontemporal resolutionauditory perceptionpsychoacoustics

Outcome Measures

Primary Outcomes (1)

  • gap detection test

    half hour

Study Arms (1)

1

Normal-hearing adults between 18 and 31 years of age.

Eligibility Criteria

Age18 Years - 31 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal-hearing adults between 18 and 31 years of age were evaluated, including 50 males (mean age 24.72 years) and 50 females (mean age 23.77 years). The youngest male subject was 18 years old, and the youngest female subject was 18.16 years old. In contrast, the oldest male subject was 31.5 years old, and the oldest female subject was 31.83 years old. All of the participants in the study were students or employees of the University of Guarulhos.

You may qualify if:

  • 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;
  • % or higher correct responses for each ear in the dichotic digit test.

You may not qualify if:

  • Hearing loss;
  • Auditory processing disorder;
  • Histories of audiologic, otologic, head trauma, and neurologic involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Study Officials

  • alessandra G. Samelli, Doctor

    Guarulhos University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

March 1, 2003

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations