Hearing Loss, SensorineuralCINTNCT00724347
PC-Based Rehabilitation of Auditory Function
A study testing Consonant Identification Training in people with Hearing Loss, Sensorineural, run by US Department of Veterans Affairs.
Trial summary
Many older subjects experience difficulty in understanding speech in noisy environments. Part of this problem is related to changes that occur in the ear with age and compromise the hearing of high-pitched sounds. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Consonant Identification Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2013
- 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 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older subjects with normal hearing.
- Older subjects with mild sensorineural hearing loss who have recently received hearing aids.
- Some young subjects with normal hearing for developing training paradigms.
Who cannot join
- Health problems that would preclude training.
- Dementia.
About this study
Official title: PC-based Rehabilitation of Auditory Function
Many older subjects experience difficulty in understanding speech in noisy environments. Part of this problem is related to changes that occur in the ear with age and compromise the hearing of high-pitched sounds. Another part of the problem with speech understanding relates to changes with age in the neural circuits of the brain that process different speech sounds. Evidence suggests that these changes in neural circuits are particularly large if hearing loss is present. Thus, while hearing aids may help compensate for hearing deficits by amplifying speech sounds, additional treatment is necessary to restore optimal neural connections in the brain so that speech sounds can be accurately distinguished from each other. We are developing PC-based training programs in an attempt to restore optimal neural connections. The current randomized trial will evaluate whether two months of training to improve the ability to discriminate different consonant sounds in noise will also improve the understanding of continuous speech and enhance auditory memory and other high-level auditory functions.
Read the detailed description
More than 300,000 veterans with sensorineural hearing loss (SNHL) are fitted with VA-issued hearing aids (HAs) each year with the primary goal of improving their understanding of speech. Even older veterans without hearing loss experience a gradual decline in speech discrimination due to age-related changes in auditory function that compromise speech understanding in everyday environments. Neuroplastic reorganization within the central auditory system due to SNHL and aging contribute to these effects and compromise subjects' ability to process phonetic cues that are essential for understanding speech in noise. As a consequence, even when a HA restores high frequency signals to the cochlea in a patient with SNHL, speech understanding will remain suboptimal in the absence of rehabilitative perceptual learning.
We have developed perceptual learning paradigms that drive this rehabilitative reorganization and significantly improve speech discrimination in new HA users. We now propose to test improved training paradigms in new and experienced HA users and older subjects with normal hearing. In Exp. 1 we will evaluate baseline speech discrimination in these populations using speech-reception thresholds (SRTs) in sentences, consonant-vowel-consonant nonsense syllable tests (CVC-NST), tests of tone-pattern discrimination, and tests of auditory short-term verbal memory (ASTVM). An analysis of the correlations of these measures will provide information about basic processes underlying impaired word and sentence identification. In Exp. 2 we will investigate the effects of CVC-identification training using performance-adapted masking noise. Based on our previous results, we anticipate that training will significantly improve CVC-NST scores. We will examine the extent to which training improves SRTs, tone-pattern processing, and ASTVM. In Exp. 3 we will train subjects in a tone-pattern identification task to evaluate the extent to which non-phonetic factors (e.g., familiarity with the computerized hearing tests, placebo effects of training, improvements in auditory attention, etc.) may contribute to training benefit. In Exp. 4 we will compare the benefits of training with single-consonant syllables with the benefits of two-consonant syllable training studied in Exp. 2. Finally, in Exp. 5 we will study the benefits of CVC training using consonant-specific noise levels adjusted to compensate for intrinsic differences in the discriminability of different consonants and compare them to the benefits of global adaptive training from Exp. 2. The experiments will clarify fundamental mechanisms underlying deficits in speech discrimination and ASTVM, provide insight into the nature of training-related improvements, and elucidate the parameters needed to optimize hearing rehabilitation.
Relevance to the VA patient care mission: HAs are relatively ineffective in improving the ability of hearing-impaired subjects to understand speech in many everyday listening situations. These experiments will clarify the extent to which perceptual training can improve speech discrimination and enhance ASTVM in these conditions in new and experienced HA users and older subjects with normal hearing. Perceptual training could potentially benefit millions of veterans who wear HAs as well as older veterans with normal hearing who experience difficulties in understanding and remembering speech.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Consonant Identification Training
- Keywords
- Auditory Perception, Hearing Loss, Presbycusis, Perceptual Learning, Hearing Prosthesis, Speech Discrimination, Delayed Treatment
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consonant Identification TrainingBehavioural
Subjects received psychophysically adaptive, consonant identification training in consonant discrimination on PCs in their homes.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Hearing impaired listeners with hearing aids underwent two months of consonant identification training in their homes. Receives: Behavioral: Consonant Identification Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
.Speech Discrimination Ability
Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.
Measured: Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2013
- Study completionMar 2013
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David L. Woods, PhD, Principal investigator, VA Northern California HCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724347
- Sponsor's protocol ID
- C4739-R
- Acronym
- CINT
- Status last verified
- Jan 2015
- First submitted
- 24 Jul 2008
- Last updated
- 27 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Woods DL, Doss Z, Herron TJ, Yund EW. Age-related changes in consonant and sentence processing. J Rehabil Res Dev. 2012;49(8):1277-91. doi: 10.1682/jrrd.2011.08.0150.
PubMed 23341320Woods DL, Yund EW, Herron TJ, Ua Cruadhlaoich MA. Consonant identification in consonant-vowel-consonant syllables in speech-spectrum noise. J Acoust Soc Am. 2010 Mar;127(3):1609-23. doi: 10.1121/1.3293005.
PubMed 20329860Woods DL, Yund EW, Herron TJ. Measuring consonant identification in nonsense syllables, words, and sentences. J Rehabil Res Dev. 2010;47(3):243-60. doi: 10.1682/jrrd.2009.04.0040.
PubMed 20665350Yund EW, Woods DL. Content and procedural learning in repeated sentence tests of speech perception. Ear Hear. 2010 Dec;31(6):769-78. doi: 10.1097/AUD.0b013e3181e68e4a.
PubMed 20562624
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PC-based Rehabilitation of Auditory Function
- ClinicalTrials.gov ID
- NCT00724347
- Acronym / sponsor ID
- CINT / C4739-R
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Auditory Perception, Hearing Loss, Presbycusis, Perceptual Learning, Hearing Prosthesis, Speech Discrimination, Delayed Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 13 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many older subjects experience difficulty in understanding speech in noisy environments. Part of this problem is related to changes that occur in the ear with age and compromise the hearing of high-pitched sounds. Another part of the problem with speech understanding relates to changes with age in the neural circuits of the brain that process different speech sounds. Evidence suggests that these changes in neural circuits are particularly large if hearing loss is present. Thus, while hearing aids may help compensate for hearing deficits by amplifying speech sounds, additional treatment is necessary to restore optimal neural connections in the brain so that speech sounds can be accurately distinguished from each other. We are developing PC-based training programs in an attempt to restore optimal neural connections. The current randomized trial will evaluate whether two months of training to improve the ability to discriminate different consonant sounds in noise will also improve the understanding of continuous speech and enhance auditory memory and other high-level auditory functions.
Detailed description
More than 300,000 veterans with sensorineural hearing loss (SNHL) are fitted with VA-issued hearing aids (HAs) each year with the primary goal of improving their understanding of speech. Even older veterans without hearing loss experience a gradual decline in speech discrimination due to age-related changes in auditory function that compromise speech understanding in everyday environments. Neuroplastic reorganization within the central auditory system due to SNHL and aging contribute to these effects and compromise subjects' ability to process phonetic cues that are essential for understanding speech in noise. As a consequence, even when a HA restores high frequency signals to the cochlea in a patient with SNHL, speech understanding will remain suboptimal in the absence of rehabilitative perceptual learning.
We have developed perceptual learning paradigms that drive this rehabilitative reorganization and significantly improve speech discrimination in new HA users. We now propose to test improved training paradigms in new and experienced HA users and older subjects with normal hearing. In Exp. 1 we will evaluate baseline speech discrimination in these populations using speech-reception thresholds (SRTs) in sentences, consonant-vowel-consonant nonsense syllable tests (CVC-NST), tests of tone-pattern discrimination, and tests of auditory short-term verbal memory (ASTVM). An analysis of the correlations of these measures will provide information about basic processes underlying impaired word and sentence identification. In Exp. 2 we will investigate the effects of CVC-identification training using performance-adapted masking noise. Based on our previous results, we anticipate that training will significantly improve CVC-NST scores. We will examine the extent to which training improves SRTs, tone-pattern processing, and ASTVM. In Exp. 3 we will train subjects in a tone-pattern identification task to evaluate the extent to which non-phonetic factors (e.g., familiarity with the computerized hearing tests, placebo effects of training, improvements in auditory attention, etc.) may contribute to training benefit. In Exp. 4 we will compare the benefits of training with single-consonant syllables with the benefits of two-consonant syllable training studied in Exp. 2. Finally, in Exp. 5 we will study the benefits of CVC training using consonant-specific noise levels adjusted to compensate for intrinsic differences in the discriminability of different consonants and compare them to the benefits of global adaptive training from Exp. 2. The experiments will clarify fundamental mechanisms underlying deficits in speech discrimination and ASTVM, provide insight into the nature of training-related improvements, and elucidate the parameters needed to optimize hearing rehabilitation.
Relevance to the VA patient care mission: HAs are relatively ineffective in improving the ability of hearing-impaired subjects to understand speech in many everyday listening situations. These experiments will clarify the extent to which perceptual training can improve speech discrimination and enhance ASTVM in these conditions in new and experienced HA users and older subjects with normal hearing. Perceptual training could potentially benefit millions of veterans who wear HAs as well as older veterans with normal hearing who experience difficulties in understanding and remembering speech.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Consonant Identification TrainingHearing impaired listeners with hearing aids underwent two months of consonant identification training in their homes. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older subjects with normal hearing.
- Older subjects with mild sensorineural hearing loss who have recently received hearing aids.
- Some young subjects with normal hearing for developing training paradigms.
Key exclusion criteria (2 listed)
- Health problems that would preclude training.
- Dementia.
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 |
|---|---|---|
| Consonant Identification TrainingSubjects received psychophysically adaptive, consonant identification training in consonant discrimination on PCs in their homes. | Behavioural | Arm 1 |
Primary outcome
.Speech Discrimination Ability
Time frame: Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..
Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23341320Woods DL, Doss Z, Herron TJ, Yund EW. Age-related changes in consonant and sentence processing. J Rehabil Res Dev. 2012;49(8):1277-91. doi: 10.1682/jrrd.2011.08.0150.
- Results publication: PubMed 20329860Woods DL, Yund EW, Herron TJ, Ua Cruadhlaoich MA. Consonant identification in consonant-vowel-consonant syllables in speech-spectrum noise. J Acoust Soc Am. 2010 Mar;127(3):1609-23. doi: 10.1121/1.3293005.
- Results publication: PubMed 20665350Woods DL, Yund EW, Herron TJ. Measuring consonant identification in nonsense syllables, words, and sentences. J Rehabil Res Dev. 2010;47(3):243-60. doi: 10.1682/jrrd.2009.04.0040.
- Results publication: PubMed 20562624Yund EW, Woods DL. Content and procedural learning in repeated sentence tests of speech perception. Ear Hear. 2010 Dec;31(6):769-78. doi: 10.1097/AUD.0b013e3181e68e4a.
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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.
David L. Woods, PhD principal investigator
VA Northern California HCS
Questions about this trial
What is this clinical trial studying?
A study testing Consonant Identification Training in people with Hearing Loss, Sensorineural, 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 2 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 27 Jan 2015. 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 13 Jan 2015). 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?
.Speech Discrimination Ability (time frame: Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724347, which also lists 4 linked publications.
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 27 Jan 2015.