An interventional study of Audiological Evaluation in Hearing Loss, sponsored by US Department of Veterans Affairs. Completed. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-08.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
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.
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:
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:
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:
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 78 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)
Procedure: Audiological Evaluation
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)
Procedure: Audiological Evaluation
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)
Procedure: Audiological Evaluation
Tests of hearing, cognition, and speech perception
Ability to Understand Speech in Noise Background
Measure speech perception for sentences in background noise
Time frame: one year
Veterans from 50 to 75 years of age with hearing loss, not hearing aid wearers
| Milestone | Mild HL | Mod HL | ModSev HL |
|---|---|---|---|
| Started | 49 | 20 | 9 |
| Completed | 32 | 13 | 7 |
| Not completed | 17 | 7 | 2 |
| Withdrew: Death | 4 | 0 | 0 |
| Withdrew: Withdrawal by subject | 7 | 4 | 0 |
| Withdrew: Lost to follow-up | 6 | 3 | 2 |
Measure speech perception for sentences in background noise
| Percent correct of 100 presented words | Mild HL | Mod HL | ModSev HL |
|---|---|---|---|
| Ability to Understand Speech in Noise Background | 84 ± 4.0 | 78 ± 7.0 | 47 ± 9.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 6/69 (8.7%) | — |
| Event | Arm 1 |
|---|---|
| Death or terminal illnessGeneral disorders | 6/69 |
Number of participants who completed the study
| Age, Continuous(years) | Mild HL | Mod HL | ModSev HL | Total |
|---|---|---|---|---|
| Mean | 59.9 ± 6.8 | 62.7 ± 7.0 | 65.1 ± 5.1 | 61.7 ± 5.1 |
| Sex: Female, Male(Participants) | Mild HL | Mod HL | ModSev HL | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 1 | 3 |
| Male | 31 | 12 | 6 | 49 |
No study locations are listed for this record.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs