Clinical Applications for Time-Compressed Speech Tests
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audiological Evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Hearing Aids, Rehabilitation of hearing impaired
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Mild Hearing Loss
Moderate Hearing Loss
Moderate-Severe Hearing Loss
Arm Description
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)
Outcomes
Primary Outcome Measures
Ability to Understand Speech in Noise Background
Measure speech perception for sentences in background noise
Secondary Outcome Measures
Full Information
NCT ID
NCT00371839
First Posted
August 31, 2006
Last Updated
November 19, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00371839
Brief Title
Clinical Applications for Time-Compressed Speech Tests
Official Title
Clinical Applications for Time-Compressed Speech Tests
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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:
subjects with TCS test scores in the highest quartile (the HIGH group)
subjects with TCS test scores in the lowest quartile (the LOW group)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Loss, Hearing Aids, Rehabilitation of hearing impaired
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild Hearing Loss
Arm Type
Active Comparator
Arm Description
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)
Arm Title
Moderate Hearing Loss
Arm Type
Active Comparator
Arm Description
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)
Arm Title
Moderate-Severe Hearing Loss
Arm Type
Active Comparator
Arm Description
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)
Intervention Type
Procedure
Intervention Name(s)
Audiological Evaluation
Intervention Description
Tests of hearing, cognition, and speech perception
Primary Outcome Measure Information:
Title
Ability to Understand Speech in Noise Background
Description
Measure speech perception for sentences in background noise
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie R. Leek, PhD
Organizational Affiliation
VA Loma Linda Healthcare System, Loma Linda, CA
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.ncrar.research.va.gov/Index.asp
Description
This is the web page of the VA research Center where the study took place
Learn more about this trial
Clinical Applications for Time-Compressed Speech Tests
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