Auditory PerceptionNCT00593788
The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults
An observational study of Auditory Perception and Psychoacoustics, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Perception, Psychoacoustics
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2003to Jun 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 31 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Hearing loss;
- Auditory processing disorder;
- Histories of audiologic, otologic, head trauma, and neurologic involvement.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Auditory Perception, Psychoacoustics
- Keywords
- GIN test, gap detection, temporal resolution, auditory perception, psychoacoustics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal-hearing adults between 18 and 31 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gap detection test
Measured: half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMar 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- alessandra G. Samelli, Doctor, Principal investigator, Guarulhos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593788
- Sponsor's protocol ID
- 113 / 02
- Other IDs
- 113/02 de 03/13/2002
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults
- ClinicalTrials.gov ID
- NCT00593788
- Acronym / sponsor ID
- 113 / 02
- Conditions
- Auditory Perception, Psychoacoustics
- Keywords
- GIN test, gap detection, temporal resolution, auditory perception, psychoacoustics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Normal-hearing adults between 18 and 31 years of age. |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Hearing loss;
- Auditory processing disorder;
- Histories of audiologic, otologic, head trauma, and neurologic involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gap detection test
Time frame: half hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alessandra G. Samelli, Doctor principal investigator
Guarulhos University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auditory Perception and Psychoacoustics, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gap detection test (time frame: half hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.