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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC001641 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Hearing | Active Comparator | Signal processing to improve intelligibility |
|
| Mild hearing loss | Active Comparator | Signal processing to improve intelligibility |
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| Moderate hearing loss | Active Comparator | Signal processing to improve intelligibility |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signal processing to improve intelligibility | Other | Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pure-tone Average Thresholds | Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears. | 6 months |
| F1 Discrimination Threshold | Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds. | 6 months |
| F2 Discrimination Threshold | Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli. | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurel H Carney, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37224720 | Result | Carney LH, Cameron DA, Kinast KB, Feld CE, Schwarz DM, Leong UC, McDonough JM. Effects of sensorineural hearing loss on formant-frequency discrimination: Measurements and models. Hear Res. 2023 Aug;435:108788. doi: 10.1016/j.heares.2023.108788. Epub 2023 May 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Mild Hearing Loss |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pure-tone Average Thresholds | Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears. | Posted | Mean | Standard Deviation | Hearing level in dB SPL | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No Adverse events occurred. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurel H. Carney | University of Rochester | 585-276-3948 | Laurel_Carney@URMC.Rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2018 | Oct 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Signal processing to improve intelligibility Signal processing to improve intelligibility: Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Audiometric Thresholds | Audiometric thresholds of subjects at 2000 Hz, a frequency where formant-frequency discrimination was measured. | Mean | Standard Deviation | decibels |
|
|
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| Primary | F1 Discrimination Threshold | Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds. | The analysis populations were determined based on the pure-tone average thresholds (outcome measure 1) | Posted | Mean | Standard Deviation | % frequency | 6 months |
|
|
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| Primary | F2 Discrimination Threshold | Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli. | The groups of subjects were determined by the pure tone average thresholds, from Outcome Measure 1. | Posted | Mean | Standard Deviation | % frequency | 6 month |
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 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. No Adverse events occurred. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | 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. No Adverse events occurred. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |