Trial Outcomes & Findings for Hearing Study: Sensitivity to Features of Speech Sounds (NCT NCT03666676)
NCT ID: NCT03666676
Last Updated: 2025-05-29
Results Overview
Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-29
Participant Flow
Participant milestones
| Measure |
Normal Hearing
Signal processing to improve intelligibility
Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Mild Hearing Loss
Signal processing to improve intelligibility
Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Moderate Hearing Loss
Signal processing to improve intelligibility
Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
16
|
15
|
|
Overall Study
COMPLETED
|
23
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hearing Study: Sensitivity to Features of Speech Sounds
Baseline characteristics by cohort
| Measure |
Normal Hearing
n=36 Participants
Signal processing to improve intelligibility
Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Mild Hearing Loss
n=16 Participants
Signal processing to improve intelligibility
Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Moderate Hearing Loss
n=15 Participants
Signal processing to improve intelligibility
Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Total
n=67 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
|
35 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 15 • n=5 Participants
|
60 years
STANDARD_DEVIATION 11 • n=7 Participants
|
60 years
STANDARD_DEVIATION 19 • n=5 Participants
|
45 years
STANDARD_DEVIATION 21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Audiometric Thresholds
|
5.5 decibels
STANDARD_DEVIATION 7.0 • n=5 Participants
|
23.8 decibels
STANDARD_DEVIATION 5.2 • n=7 Participants
|
46.1 decibels
STANDARD_DEVIATION 6.9 • n=5 Participants
|
17.0 decibels
STANDARD_DEVIATION 17.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsHearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears.
Outcome measures
| Measure |
Normal Hearing
n=23 Participants
Participants with normal hearing
|
Mild Hearing Loss
n=8 Participants
Participants with mild hearing loss
|
Moderate Hearing Loss
n=3 Participants
Participants with moderate hearing loss.
|
|---|---|---|---|
|
Pure-tone Average Thresholds
|
7.3 Hearing level in dB SPL
Standard Deviation 6.3
|
30.8 Hearing level in dB SPL
Standard Deviation 6.0
|
46.9 Hearing level in dB SPL
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis populations were determined based on the pure-tone average thresholds (outcome measure 1)
Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds.
Outcome measures
| Measure |
Normal Hearing
n=23 Participants
Participants with normal hearing
|
Mild Hearing Loss
n=8 Participants
Participants with mild hearing loss
|
Moderate Hearing Loss
n=3 Participants
Participants with moderate hearing loss.
|
|---|---|---|---|
|
F1 Discrimination Threshold
|
5 % frequency
Standard Deviation 2.3
|
7.8 % frequency
Standard Deviation 5.5
|
5.9 % frequency
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 6 monthPopulation: The groups of subjects were determined by the pure tone average thresholds, from Outcome Measure 1.
Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli.
Outcome measures
| Measure |
Normal Hearing
n=23 Participants
Participants with normal hearing
|
Mild Hearing Loss
n=8 Participants
Participants with mild hearing loss
|
Moderate Hearing Loss
n=3 Participants
Participants with moderate hearing loss.
|
|---|---|---|---|
|
F2 Discrimination Threshold
|
4 % frequency
Standard Deviation 2.9
|
21 % frequency
Standard Deviation 11.3
|
30.8 % frequency
Standard Deviation 6.2
|
Adverse Events
Normal Hearing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild Hearing Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Hearing Loss
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place