Hearing LossNCT00371839
Clinical Applications for Time-Compressed Speech Tests
A study testing Audiological Evaluation in people with Hearing Loss, run by US Department of Veterans Affairs.
Trial summary
The purpose of this study is to determine the effects of age-related cognitive changes on hearing aid benefit based on hearing aid compression time constants. The hypothesis is that people with poor working memory skills will benefit from slow time constants in hearing aid compression while those with good working… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Audiological Evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be 50 to 75 years old.
- Hearing loss will be limited to 40 dB HL from 250 Hz through 1000 Hz, and to 60 dB HL through 4000 Hz.
- Hearing loss must be greater than 25 dB at two or more frequencies from 250 to 4000 Hz.
Who cannot join
- None of the participants will be current or past hearing aid users; all will be free of ear disease.
- Participants with conductive hearing losses, defined as air-bone gap greater than 15 dB, will be excluded.
- The audiometric battery with acoustic reflex thresholds and decay measurements will be used to exclude anyone with evidence of a central disorder or a pathology other than a sensorineural loss. Those potential participants will be referred to a medical professional.
About this study
The purpose of this study is to determine the effects of age-related cognitive changes on hearing aid benefit based on hearing aid compression time constants.
The hypothesis is that people with poor working memory skills will benefit from slow time constants in hearing aid compression while those with good working memory skills will be able to benefit from more sophisticated compression algorithms with rapid time constants.
Read the detailed description
Recent research has shown the relevance of cognitive function in hearing aid evaluation and the sensitivity of the aging auditory system to temporal distortions. The proposed investigation will examine the interaction of working memory and hearing aid compression method on speech recognition in background competition for older listeners. This interaction will be investigated for the following three forms of background competition:
- Competition from continuous speech-shaped noise.
- Competition from speech-modulated noise.
- Competition from a single interfering talker.
The goals of the study will be accomplished in two phases. In the first phase, 160 adults aged 50 through 75 years will be evaluated on a battery of tests to determine their cognitive capacity, time-compressed speech scores and their candidacy for inclusion in the second phase of the study. At the conclusion of this phase of testing, the participants will be divided into three groups:
- subjects with TCS test scores in the highest quartile (the HIGH group)
- subjects with TCS test scores in the lowest quartile (the LOW group)
- the remaining listeners
The second phase of the experiment will include listeners from the HIGH and LOW groups only. These subjects will be evaluated with respect to their speech recognition ability for three types of interference (steady-state noise, speech-modulated noise, single interfering talker). The HINT test (Nilsson, Soli, \& Sumida, 1995; Nilsson et al., 1994) will be used to obtain the signal-to-noise ratio (SNR) at 50% recognition for the three masking conditions for each of three types of amplification:
- one- channel linear amplification (LINEAR) with frequency shaping
- two-channel wide dynamic range compression with fast time constants (FAST)
- two-channel wide dynamic range compression with slow time constants (SLOW) Listener groups will be compared across hearing aid conditions and across background interference conditions.
- Conditions
- Hearing Loss
- Being tested
- Audiological Evaluation
- Keywords
- Hearing Loss, Hearing Aids, Rehabilitation of hearing impaired
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiological EvaluationProcedure or surgery
Tests of hearing, cognition, and speech perception
| Study group | Role | What they receive |
|---|---|---|
| Mild Hearing Loss | Active comparator | Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL) Receives: Procedure: Audiological Evaluation |
| Moderate Hearing Loss | Active comparator | Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL) Receives: Procedure: Audiological Evaluation |
| Moderate-Severe Hearing Loss | Active comparator | Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL) Receives: Procedure: Audiological Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Understand Speech in Noise Background
Measure speech perception for sentences in background noise
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marjorie R. Leek, PhD, Principal investigator, VA Loma Linda Healthcare System, Loma Linda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371839
- Sponsor's protocol ID
- C4338-R
- Status last verified
- Nov 2014
- First submitted
- 31 Aug 2006
- Last updated
- 8 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications for Time-Compressed Speech Tests
- ClinicalTrials.gov ID
- NCT00371839
- Acronym / sponsor ID
- C4338-R
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, Hearing Aids, Rehabilitation of hearing impaired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 19 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of age-related cognitive changes on hearing aid benefit based on hearing aid compression time constants.
The hypothesis is that people with poor working memory skills will benefit from slow time constants in hearing aid compression while those with good working memory skills will be able to benefit from more sophisticated compression algorithms with rapid time constants.
Detailed description
Recent research has shown the relevance of cognitive function in hearing aid evaluation and the sensitivity of the aging auditory system to temporal distortions. The proposed investigation will examine the interaction of working memory and hearing aid compression method on speech recognition in background competition for older listeners. This interaction will be investigated for the following three forms of background competition:
- Competition from continuous speech-shaped noise.
- Competition from speech-modulated noise.
- Competition from a single interfering talker.
The goals of the study will be accomplished in two phases. In the first phase, 160 adults aged 50 through 75 years will be evaluated on a battery of tests to determine their cognitive capacity, time-compressed speech scores and their candidacy for inclusion in the second phase of the study. At the conclusion of this phase of testing, the participants will be divided into three groups:
- subjects with TCS test scores in the highest quartile (the HIGH group)
- subjects with TCS test scores in the lowest quartile (the LOW group)
- the remaining listeners
The second phase of the experiment will include listeners from the HIGH and LOW groups only. These subjects will be evaluated with respect to their speech recognition ability for three types of interference (steady-state noise, speech-modulated noise, single interfering talker). The HINT test (Nilsson, Soli, \& Sumida, 1995; Nilsson et al., 1994) will be used to obtain the signal-to-noise ratio (SNR) at 50% recognition for the three masking conditions for each of three types of amplification:
- one- channel linear amplification (LINEAR) with frequency shaping
- two-channel wide dynamic range compression with fast time constants (FAST)
- two-channel wide dynamic range compression with slow time constants (SLOW) Listener groups will be compared across hearing aid conditions and across background interference conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hearing Loss | Active comparator | Procedure: Audiological EvaluationAudiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL) |
| Moderate Hearing Loss | Active comparator | Procedure: Audiological EvaluationAudiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL) |
| Moderate-Severe Hearing Loss | Active comparator | Procedure: Audiological EvaluationAudiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be 50 to 75 years old.
- Hearing loss will be limited to 40 dB HL from 250 Hz through 1000 Hz, and to 60 dB HL through 4000 Hz.
- Hearing loss must be greater than 25 dB at two or more frequencies from 250 to 4000 Hz.
Key exclusion criteria (3 listed)
- None of the participants will be current or past hearing aid users; all will be free of ear disease.
- Participants with conductive hearing losses, defined as air-bone gap greater than 15 dB, will be excluded.
- The audiometric battery with acoustic reflex thresholds and decay measurements will be used to exclude anyone with evidence of a central disorder or a pathology other than a sensorineural loss. Those potential participants will be referred to a medical professional.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiological EvaluationTests of hearing, cognition, and speech perception | Procedure or surgery | Mild Hearing Loss, Moderate Hearing Loss, Moderate-Severe Hearing Loss |
Primary outcome
Ability to Understand Speech in Noise Background
Time frame: one year
Measure speech perception for sentences in background noise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- This is the web page of the VA research Center where the study took placeLink provided by the sponsor.
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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.
Marjorie R. Leek, PhD principal investigator
VA Loma Linda Healthcare System, Loma Linda, CA
Questions about this trial
What is this clinical trial studying?
A study testing Audiological Evaluation in people with Hearing Loss, run by US Department of Veterans Affairs.
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 3 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 19 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ability to Understand Speech in Noise Background (time frame: one year). 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 8 Dec 2014.