Clinical Applications for Time-Compressed Speech Tests - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00371839

Purpose

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.

Condition	Intervention
Hearing Loss	Procedure: Audiological Evaluation

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Clinical Applications for Time-Compressed Speech Tests

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Ability to understand speech in noise background [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Study performance on cognitive and hearing tests	Procedure: Audiological Evaluation Tests of hearing, cognition, and speech perception

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:

1. subjects with TCS test scores in the highest quartile (the HIGH group) 2. subjects with TCS test scores in the lowest quartile (the LOW group) 3. 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.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371839

Contacts

Contact: Marjorie R Leek, PhD

(503) 220-8262

marjorie.leek@va.gov

Locations

United States, Oregon
VA Medical Center, Portland	Recruiting
Portland, Oregon, United States, 97201
Contact: Bonnie Becker 503-220-8262 ext 54525 Bonnie.Becker@va.gov
Contact: Michelle R Molis, PhD (503) 220-8262 ext 55574 Michelle.Molis@va.gov
Principal Investigator: Marjorie R. Leek, PhD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Marjorie R. Leek, PhD

VA Medical Center, Portland

More Information

Additional Information:

Click here for more information about this study: Clinical Applications for Time-Compressed Speech Tests This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Department of Veterans Affairs ( Leek, Marjorie - Principal Investigator )
Study ID Numbers:	C4338R
Study First Received:	August 31, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00371839 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Hearing Loss
Hearing Aids
Rehabilitation of hearing impaired

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness

Otorhinolaryngologic Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

ClinicalTrials.gov processed this record on May 07, 2009