PC-Based Rehabilitation of Auditory Function (Hearing-Rehab)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00724347
First received: July 24, 2008
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention
Hearing Loss, Sensorineural
Behavioral: PC-Based Consonant Discrimination Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: PC-based Rehabilitation of Auditory Function

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Computer measurements of syllable processing, auditory short-term verbal memory, sentence reception, and auditory pattern discrimination. [ Time Frame: Subjects will receive two months of PC training and be tested over an eight-month period. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Behavioral: PC-Based Consonant Discrimination Training
Subjects will receive adaptive training in consonant discrimination on PCs in their homes.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724347

Locations
United States, California
VA Northern California HCS
Martinez, California, United States, 94553
Sponsors and Collaborators
Investigators
Principal Investigator: David L. Woods, PhD VA Northern California HCS
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00724347     History of Changes
Other Study ID Numbers: C4739-R
Study First Received: July 24, 2008
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Keywords provided by 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
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014