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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00371839
Other study ID # C4338-R
Secondary ID
Status Completed
Phase N/A
First received August 31, 2006
Last updated November 19, 2014
Start date September 2006
Est. completion date December 2011

Study information

Verified date November 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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 memory skills will be able to benefit from more sophisticated compression algorithms with rapid time constants.


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:

1. Competition from continuous speech-shaped noise.

2. Competition from speech-modulated noise.

3. 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:

1. one- channel linear amplification (LINEAR) with frequency shaping

2. two-channel wide dynamic range compression with fast time constants (FAST)

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Audiological Evaluation
Tests of hearing, cognition, and speech perception

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to Understand Speech in Noise Background Measure speech perception for sentences in background noise one year No
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