CINT: PC-Based Rehabilitation of Auditory Function

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00724347
• Collaborator: (none)
• Enrollment: 18
• Arm: 1
• Duration (Months): 56

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural	Behavioral: Consonant Identification Training	N/A

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

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: PC-based Rehabilitation of Auditory Function
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Hearing impaired listeners with hearing aids underwent two months of consonant identification training in their homes.	Behavioral: Consonant Identification Training; Subjects received psychophysically adaptive, consonant identification training in consonant discrimination on PCs in their homes.

Outcome Measures

Primary Outcome Measures

1. .Speech Discrimination Ability [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Health problems that would preclude training.

• Dementia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: David L. Woods, PhD, VA Northern California HCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00724347
• Other Study ID Numbers: C4739-R
• First Posted: Jul 29, 2008
• Last Update Posted: Jan 27, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by US Department of Veterans Affairs: Auditory Perception; Hearing Loss; Presbycusis; Perceptual Learning; Hearing Prosthesis; Speech Discrimination; Delayed Treatment
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural

Study Results

Participant Flow

Recruitment Details	VA patients with hearing loss who wore hearing aids (HAs) were recruited from the VA audiology clinic. Control subjects of similar ages as well as young control subjects were also recruited in order to characaterize speech discrimination capabilities in normal-hearing populations.
Pre-assignment Detail	Most listeners with hearing loss were tested with and without their hearing aids prior to beginning 8 weeks of at-home PC training.

Arm/Group Title	Arm 1
Arm/Group Description	PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
Period Title: Overall Study
STARTED	18
Baseline Testing	18
COMPLETED	16
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Training Group
Arm/Group Description	Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
Overall Participants	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.67 (6.51)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 50%
>=65 years	9 50%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	18 100%
Region of Enrollment (participants) [Number]
United States	18 100%
Audiometry (Sound intensity dB HL) [Mean (Standard Deviation) ]
Thresholds 500 Hz	19.69 (13.35)
Thresholds 1000 Hz	29.38 (16.42)
Thresholds 2000 Hz	43.13 (15.15)
Thresholds 4000 Hz	66.88 (9.46)
Thresholds 6000 Hz	71.25 (12.58)

Outcome Measures

1. Primary Outcome

Title	.Speech Discrimination Ability
Description	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.
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..

Outcome Measure Data

Analysis Population Description

older hearing impaired listeners with hearing aids.

Arm/Group Title	Training Group
Arm/Group Description	Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
Measure Participants	16
Improvement in consonant thresholds	9.43 (4.84)
Improvement in sentence thresholds	0.46 (1.23)

Adverse Events

Time Frame	4 years
Arm/Group Title	Arm 1
Arm/Group Description	PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
All Cause Mortality
	Arm 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

Five publications describing the new tests that we developed have appeared.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.