Trial Outcomes & Findings for Spectral Dynamics and Speech Understanding by Hearing Impaired People (NCT NCT01867515)
NCT ID: NCT01867515
Last Updated: 2018-04-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
Results posted on
2018-04-26
Participant Flow
Participant milestones
| Measure |
Younger Normally-hearing Listeners
Participants with auditory thresholds within the normal limits.
* age 18 to 35
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
|
Older Normally-hearing Listeners
Participants with auditory thresholds within the normal limits.
* age 36 to 65
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
|
Hearing-impaired Listeners
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
25
|
|
Overall Study
COMPLETED
|
13
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spectral Dynamics and Speech Understanding by Hearing Impaired People
Baseline characteristics by cohort
| Measure |
Younger Normally-hearing Listeners
n=13 Participants
Participants with auditory thresholds within the normal limits.
* age 18 to 35
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
|
Older Normally-hearing Listeners
n=11 Participants
Participants with auditory thresholds within the normal limits.
* age 36 to 65
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
|
Hearing-impaired Listeners
n=14 Participants
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
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
26.5 years
n=5 Participants
|
59.1 years
n=7 Participants
|
59.4 years
n=5 Participants
|
48.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apartThe 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.
Outcome measures
| Measure |
Normally-hearing Listeners
n=13 Participants
Participants with auditory thresholds within the normal limits.
* age 18 to 35
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
|
Older Normally-hearing
n=11 Participants
Participants with auditory thresholds within the normal limits.
* age 36 to 65
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
|
Hearing-impaired Listeners
n=14 Participants
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
|
|---|---|---|---|
|
Percent Correct Words Identified
Unprocessed speech in noise
|
98.8 percentage of words identified
Interval 88.0 to 100.0
|
96.2 percentage of words identified
Interval 72.0 to 100.0
|
91.3 percentage of words identified
Interval 68.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed (50%) speech in quiet
|
95.7 percentage of words identified
Interval 60.0 to 100.0
|
96.4 percentage of words identified
Interval 84.0 to 100.0
|
86.4 percentage of words identified
Interval 24.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed (50%) speech in noise
|
89.5 percentage of words identified
Interval 72.0 to 100.0
|
80.2 percentage of words identified
Interval 60.0 to 96.0
|
57.9 percentage of words identified
Interval 8.0 to 92.0
|
|
Percent Correct Words Identified
Time-compressed (66%) speech in quiet
|
92.8 percentage of words identified
Interval 60.0 to 100.0
|
86.4 percentage of words identified
Interval 52.0 to 100.0
|
66.9 percentage of words identified
Interval 24.0 to 100.0
|
|
Percent Correct Words Identified
Unprocessed speech in quiet
|
98.6 percentage of words identified
Interval 88.0 to 100.0
|
97.1 percentage of words identified
Interval 84.0 to 100.0
|
91.9 percentage of words identified
Interval 64.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed (66%) speech in noise
|
47.7 percentage of words identified
Interval 8.0 to 80.0
|
26.2 percentage of words identified
Interval 4.0 to 60.0
|
11.3 percentage of words identified
Interval 0.0 to 44.0
|
|
Percent Correct Words Identified
Time-compressed (80%) speech in quiet
|
39.8 percentage of words identified
Interval 8.0 to 88.0
|
12.2 percentage of words identified
Interval 0.0 to 60.0
|
7.1 percentage of words identified
Interval 0.0 to 64.0
|
|
Percent Correct Words Identified
Time-compressed (80%) speech in noise
|
1.4 percentage of words identified
Interval 0.0 to 8.0
|
0.7 percentage of words identified
Interval 0.0 to 4.0
|
0.3 percentage of words identified
Interval 0.0 to 4.0
|
|
Percent Correct Words Identified
Interrupted (50%) speech in quiet
|
98.5 percentage of words identified
Interval 88.0 to 100.0
|
96.2 percentage of words identified
Interval 80.0 to 100.0
|
85.6 percentage of words identified
Interval 56.0 to 100.0
|
|
Percent Correct Words Identified
Interrupted (50%) speech in noise
|
89.7 percentage of words identified
Interval 68.0 to 100.0
|
84.7 percentage of words identified
Interval 64.0 to 100.0
|
58.7 percentage of words identified
Interval 20.0 to 92.0
|
|
Percent Correct Words Identified
Interrupted (66%) speech in quiet
|
98.3 percentage of words identified
Interval 88.0 to 100.0
|
94.9 percentage of words identified
Interval 80.0 to 100.0
|
73.3 percentage of words identified
Interval 24.0 to 100.0
|
|
Percent Correct Words Identified
Interrupted (66%) speech in noise
|
69.8 percentage of words identified
Interval 40.0 to 84.0
|
60.7 percentage of words identified
Interval 24.0 to 84.0
|
36.6 percentage of words identified
Interval 8.0 to 84.0
|
|
Percent Correct Words Identified
Interrupted (80%) speech in quiet
|
86.3 percentage of words identified
Interval 60.0 to 100.0
|
70.7 percentage of words identified
Interval 8.0 to 92.0
|
46.1 percentage of words identified
Interval 4.0 to 96.0
|
|
Percent Correct Words Identified
Interrupted (80%) speech in noise
|
47.1 percentage of words identified
Interval 20.0 to 84.0
|
38.9 percentage of words identified
Interval 4.0 to 60.0
|
19.7 percentage of words identified
Interval 0.0 to 64.0
|
|
Percent Correct Words Identified
Time-compressed/Expanded (50%) speech in quiet
|
98.5 percentage of words identified
Interval 84.0 to 100.0
|
96.7 percentage of words identified
Interval 88.0 to 100.0
|
86.3 percentage of words identified
Interval 36.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed/Expanded (50%) speech in noise
|
93.4 percentage of words identified
Interval 84.0 to 100.0
|
86.9 percentage of words identified
Interval 56.0 to 100.0
|
69.1 percentage of words identified
Interval 32.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed/Expanded (66%) speech in quiet
|
98 percentage of words identified
Interval 72.0 to 100.0
|
95.6 percentage of words identified
Interval 80.0 to 100.0
|
77.4 percentage of words identified
Interval 40.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed/Expanded (66%) speech in noise
|
83.7 percentage of words identified
Interval 40.0 to 100.0
|
72.7 percentage of words identified
Interval 24.0 to 92.0
|
50.7 percentage of words identified
Interval 10.0 to 96.0
|
|
Percent Correct Words Identified
Time-compressed/Expanded (80%) speech in quiet
|
93.7 percentage of words identified
Interval 64.0 to 100.0
|
89.5 percentage of words identified
Interval 56.0 to 100.0
|
66 percentage of words identified
Interval 24.0 to 100.0
|
|
Percent Correct Words Identified
Time-compressed/Expanded (80%) speech in noise
|
75.7 percentage of words identified
Interval 40.0 to 100.0
|
57.6 percentage of words identified
Interval 32.0 to 76.0
|
30 percentage of words identified
Interval 4.0 to 76.0
|
Adverse Events
Younger Normally-hearing Listeners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Older Normally-hearing Listeners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hearing-impaired Listeners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle R. Molis, PhD
VA Portland HCS, RR&D National Center for Auditory Rehabilitative Research
Phone: 503-220-8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place