Hearing Loss, Sensorineural
Conditions
Brief summary
The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.
Detailed description
The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these chirps are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.
Interventions
OTHERSignal processing to improve intelligibility
Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal hearing, mild or moderate symmetric sensorineural hearing loss.
Exclusion criteria
* Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz). * Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pure-tone Average Thresholds | 6 months | Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears. |
| F1 Discrimination Threshold | 6 months | Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds. |
| F2 Discrimination Threshold | 6 month | Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 16 |
| 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. | 15 |
| Total | 67 |
Baseline characteristics
| Characteristic | Normal Hearing | Mild Hearing Loss | Moderate Hearing Loss | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 9 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 7 Participants | 6 Participants | 48 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 15 | 60 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 19 | 45 years STANDARD_DEVIATION 21 |
| Audiometric Thresholds | 5.5 decibels STANDARD_DEVIATION 7 | 23.8 decibels STANDARD_DEVIATION 5.2 | 46.1 decibels STANDARD_DEVIATION 6.9 | 17.0 decibels STANDARD_DEVIATION 17.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 16 Participants | 14 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 14 Participants | 15 Participants | 55 Participants |
| Region of Enrollment United States | 36 participants | 16 participants | 15 participants | 67 participants |
| Sex: Female, Male Female | 20 Participants | 13 Participants | 9 Participants | 42 Participants |
| Sex: Female, Male Male | 16 Participants | 3 Participants | 6 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 36 | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 36 | 0 / 16 | 0 / 15 |
Outcome results
Primary
F1 Discrimination Threshold
Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds.
Time frame: 6 months
Population: The analysis populations were determined based on the pure-tone average thresholds (outcome measure 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Hearing | F1 Discrimination Threshold | 5 % frequency | Standard Deviation 2.3 |
| Mild Hearing Loss | F1 Discrimination Threshold | 7.8 % frequency | Standard Deviation 5.5 |
| Moderate Hearing Loss | F1 Discrimination Threshold | 5.9 % frequency | Standard Deviation 2 |
Primary
F2 Discrimination Threshold
Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli.
Time frame: 6 month
Population: The groups of subjects were determined by the pure tone average thresholds, from Outcome Measure 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Hearing | F2 Discrimination Threshold | 4 % frequency | Standard Deviation 2.9 |
| Mild Hearing Loss | F2 Discrimination Threshold | 21 % frequency | Standard Deviation 11.3 |
| Moderate Hearing Loss | F2 Discrimination Threshold | 30.8 % frequency | Standard Deviation 6.2 |
Primary
Pure-tone Average Thresholds
Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Hearing | Pure-tone Average Thresholds | 7.3 Hearing level in dB SPL | Standard Deviation 6.3 |
| Mild Hearing Loss | Pure-tone Average Thresholds | 30.8 Hearing level in dB SPL | Standard Deviation 6 |
| Moderate Hearing Loss | Pure-tone Average Thresholds | 46.9 Hearing level in dB SPL | Standard Deviation 6.6 |