An interventional study of Acoustic distortion of speech in Hearing Loss, Sensorineural, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-26.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
The purpose of this program of research is to understand the perception of the dynamic spectral properties of speech by hearing-impaired listeners, with the long-term goal of improving speech understanding by these individuals in adverse listening conditions. The proposed research compares the performance of normally-hearing and hearing-impaired listeners on measures of speech understanding in the presence of different types of signal distortion and speech understanding of signals with enhanced spectral dynamics. A computational model based on the amount of potential information available in speech will be used to quantify differences in speech intelligibility due to hearing status and stimulus characteristics.
This is a behavioral study of human auditory perception. Each experiment in this study involves prospective data collection from three types of listeners. The experimental listeners will be people with sensorineural hearing loss and the control listeners will either be subjects with normal hearing or normal-hearing listeners for whom hearing loss will be simulated through the use of a spectrally-shaped broadband noise. The tasks of the subjects in this study involve either listening to synthesized sounds over earphones while seated comfortably in a sound-treated booth, and making responses indicating the subject's auditory perception of these sounds by touching specific areas on a touch-screen terminal; or, listening to recorded, acoustically modified syllables, words, or sentences over earphones and making responses indicating the subject's identification.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
Participants with auditory thresholds within the normal limits. * age between 18 and 35 * individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech
Other: Acoustic distortion of speech
individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below * age 18 to 65 Acoustic distortion of speech
Other: Acoustic distortion of speech
Participants with auditory thresholds within the normal limits. * age between 36 and 65 * individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech
Other: Acoustic distortion of speech
Percent Correct Words Identified
The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
Time frame: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
| Milestone | Younger Normally-hearing Listeners | Older Normally-hearing Listeners | Hearing-impaired Listeners |
|---|---|---|---|
| Started | 13 | 12 | 25 |
| Completed | 13 | 11 | 14 |
| Not completed | 0 | 1 | 11 |
The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
| percentage of words identified | Normally-hearing Listeners | Older Normally-hearing | Hearing-impaired Listeners |
|---|---|---|---|
| Unprocessed speech in quiet | 98.6 (88 to 100) | 97.1 (84 to 100) | 91.9 (64 to 100) |
| Unprocessed speech in noise | 98.8 (88 to 100) | 96.2 (72 to 100) | 91.3 (68 to 100) |
| Time-compressed (50%) speech in quiet | 95.7 (60 to 100) | 96.4 (84 to 100) | 86.4 (24 to 100) |
| Time-compressed (50%) speech in noise | 89.5 (72 to 100) | 80.2 (60 to 96) | 57.9 (8 to 92) |
| Time-compressed (66%) speech in quiet | 92.8 (60 to 100) | 86.4 (52 to 100) | 66.9 (24 to 100) |
| Time-compressed (66%) speech in noise | 47.7 (8 to 80) | 26.2 (4 to 60) | 11.3 (0 to 44) |
| Time-compressed (80%) speech in quiet | 39.8 (8 to 88) | 12.2 (0 to 60) | 7.1 (0 to 64) |
| Time-compressed (80%) speech in noise | 1.4 (0 to 8) | 0.7 (0 to 4) | 0.3 (0 to 4) |
| Interrupted (50%) speech in quiet | 98.5 (88 to 100) | 96.2 (80 to 100) | 85.6 (56 to 100) |
| Interrupted (50%) speech in noise | 89.7 (68 to 100) | 84.7 (64 to 100) | 58.7 (20 to 92) |
| Interrupted (66%) speech in quiet | 98.3 (88 to 100) | 94.9 (80 to 100) | 73.3 (24 to 100) |
| Interrupted (66%) speech in noise | 69.8 (40 to 84) | 60.7 (24 to 84) | 36.6 (8 to 84) |
| Interrupted (80%) speech in quiet | 86.3 (60 to 100) | 70.7 (8 to 92) | 46.1 (4 to 96) |
| Interrupted (80%) speech in noise | 47.1 (20 to 84) | 38.9 (4 to 60) | 19.7 (0 to 64) |
| Time-compressed/Expanded (50%) speech in quiet | 98.5 (84 to 100) | 96.7 (88 to 100) | 86.3 (36 to 100) |
| Time-compressed/Expanded (50%) speech in noise | 93.4 (84 to 100) | 86.9 (56 to 100) | 69.1 (32 to 100) |
| Time-compressed/Expanded (66%) speech in quiet | 98 (72 to 100) | 95.6 (80 to 100) | 77.4 (40 to 100) |
| Time-compressed/Expanded (66%) speech in noise | 83.7 (40 to 100) | 72.7 (24 to 92) | 50.7 (10 to 96) |
| Time-compressed/Expanded (80%) speech in quiet | 93.7 (64 to 100) | 89.5 (56 to 100) | 66 (24 to 100) |
| Time-compressed/Expanded (80%) speech in noise | 75.7 (40 to 100) | 57.6 (32 to 76) | 30 (4 to 76) |
Collected over over the course of up to three 2-hour visits, spaced an average of one week apart. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Younger Normally-hearing Listeners | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Older Normally-hearing Listeners | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Hearing-impaired Listeners | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Younger Normally-hearing Listeners | Older Normally-hearing Listeners | Hearing-impaired Listeners | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 10 | 13 | 36 |
| >=65 years | 0 | 1 | 1 | 2 |
| Age, Continuous(years) | Younger Normally-hearing Listeners | Older Normally-hearing Listeners | Hearing-impaired Listeners | Total |
|---|---|---|---|---|
| Mean | 26.5 (20 to 33) | 59.1 (51 to 65) | 59.4 (48 to 65) | 48.0 (20 to 65) |
| Sex: Female, Male(Participants) | Younger Normally-hearing Listeners | Older Normally-hearing Listeners | Hearing-impaired Listeners | Total |
|---|---|---|---|---|
| Female | 6 | 5 | 2 | 13 |
| Male | 7 | 6 | 12 | 25 |
| Region of Enrollment(Participants) | Younger Normally-hearing Listeners | Older Normally-hearing Listeners | Hearing-impaired Listeners | Total |
|---|---|---|---|---|
| United States | 13 | 11 | 14 | 38 |
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