Clinical Applications for Time-Compressed Speech Tests

November 19, 2014 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mild Hearing Loss
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)
Tests of hearing, cognition, and speech perception
Active Comparator: Moderate Hearing Loss
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)
Tests of hearing, cognition, and speech perception
Active Comparator: Moderate-Severe Hearing Loss
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)
Tests of hearing, cognition, and speech perception

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to Understand Speech in Noise Background
Time Frame: one year
Measure speech perception for sentences in background noise
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marjorie R. Leek, PhD, VA Loma Linda Healthcare System, Loma Linda, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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