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| ID | Type | Description | Link |
|---|---|---|---|
| R21DC017588 | 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 objective of this study protocol is to determine the efficacy of using aided measures of spectral resolution to set the dynamic range of hearing with hearing-aid amplification. Measures of spectral resolution will be obtained, as will measures of speech recognition.
Adults with hearing loss are more vulnerable to interference from background noise than adults with normal hearing. Despite the fact that the ability to extract speech information imbedded in background noise requires decoding differences in level across frequency (spectral information), few studies have addressed the extent to which spectral information can be provided to listeners with hearing loss. This fundamental gap in our knowledge prevents society from effectively addressing the systemic effects of hearing loss on communication, income, and ability to socialize with others. This work is a new application of established methods of characterizing spectral resolution to that of the most common device for rehabilitation of hearing loss, hearing-aid amplification. Because hearing aids do not require premarket approval, FDA oversight is not applicable to this clinical trial.
The experiments will examine the degree to which access to spectral information can be restored to adults with hearing loss and the feasibility of utilizing this information to decrease interference from background noise. Aim 1 will delineate the impact of hearing-aid amplification on spectral decoding. Technology options that must be set by the clinician or hearing-aid manufacturer will be examined, including the frequency-specific gain, compressor speed, and number of compression channels. The proposed experiments will test the hypothesis that restoration of the lost dynamic range of hearing can support the encoding of spectral information. It is also hypothesized that the combination of technology options that best restore access to spectral information will differ across individuals and that these differences across individuals can be partially accounted for by an estimate of outer hair cell function. Aim 2 will determine the extent to which restoring access to spectral information supports speech recognition in background noise, under the guiding hypothesis that improving spectral resolution increases speech understanding. If it can be demonstrated that measures of spectral resolution with the provision of amplification are useful at delineating those who stand to benefit from different technology options, the knowledge gained could then be applied to the clinic to allow for clinicians to more successfully choose among different rehabilitation options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Aid | Experimental | Group of participants with hearing loss. Subjects will complete a questionnaire that asks relevant questions about their medical and developmental history and educational level. Participants will be screened for a potential cognitive impairment using the Montreal Cognitive Assessment Basic (MOCA-B). Working memory span will be assessed using the reading span test. Each subject will undergo a routine audiological examination, including audiometric testing and tympanometry. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels, while manipulating different hearing aid parameters and also without the provision of amplification, will be assessed. |
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| Normal Hearing | No Intervention | Group of participants with normal hearing that serve as a reference group. Subjects will complete a questionnaire that asks relevant questions about their medical and developmental history and educational level. Participants will be screened for a potential cognitive impairment using the Montreal Cognitive Assessment Basic (MOCA-B). Working memory span will be assessed using the reading span test. Each subject will undergo a routine audiological examination, including audiometric testing and tympanometry. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels will be assessed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid | Device | Hearing Aid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spectral Resolution | Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit. | Each test was approximately 10 minutes and was completed after each experimental manipulation |
| Speech Recognition | measure of spatial release from masking (dB) for a masker presented at 70 dB SPL. | Each test was approximately 10 minutes and was completed after each experimental manipulation |
| Measure | Description | Time Frame |
|---|---|---|
| Working Memory | Measure of working memory (correctly repeated words from the reading span test). The minimum (poorer) and maximum (better) values are 0 and 57, respectively. | Each test was approximately 30 minutes and was completed only once per subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Brennan, PhD | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barkley Memorial Center | Lincoln | Nebraska | 68583 | United States |
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Participants completed a questionnaire about their medical and developmental history and educational level. Participants cognitive ability assessed using the Montreal Cognitive Assessment Basic (MOCA-B). Each subject underwent a routine audiological examination, including audiometric testing and tympanometry. Due to not qualifying on basis of inclusion or exclusion criteria (age, degree of hearing loss, or tympanometric findings), 85 participants were excluded before assignment to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hearing Aid | Group of participants with hearing loss. Working memory span was assessed using the reading span test. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels, while manipulating different hearing aid parameters and also without the provision of amplification, was assessed. Hearing Aid: Hearing Aid |
| FG001 | Normal Hearing | Group of participants with normal hearing that serve as a reference group. Working memory span was assessed using the reading span test. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels was assessed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Hearing | Group of participants with normal hearing that serve as a reference group. |
| BG001 | Hearing Aid | Group of participants with sensorineural hearing loss who were tested under conditions with hearing aid amplification. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Spectral Resolution | Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit. | Consisted of varying conditions and number of participants per condition, including three different compression speeds (instant, fast, slow), three different number of compression channels (4, 8, 16) and two different amplification conditions (unaided, aided). | Posted | Mean | Standard Deviation | units on a scale | Each test was approximately 10 minutes and was completed after each experimental manipulation |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Hearing Aid | Group of participants with sensorineural hearing loss who were tested under conditions with hearing aid amplification. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Brennan | University of Nebraska-Lincoln | 4024723132 | marc.brennan@unl.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 | Mar 13, 2019 | Nov 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| Did Not Condition To Experiment |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Montreal Cognitive Assessment Basic (MOCA-B) | MOCA-B is a measure of cognitive ability that assess aspects of cognitive ability such as executive function, immediate recall, and delayed recall. Each task is scored and then the sum of scores across tasks is computed. The range of possible scores is 0 to 30 (with 30 indicating perfect cognitive ability per this assessment). | Mean | Full Range | scores on a scale |
|
| OG001 | Normal Hearing | Comparison group of individuals with normal hearing. This group was only tested without hearing aid amplification (in the unaided condition). |
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|
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| Primary | Speech Recognition | measure of spatial release from masking (dB) for a masker presented at 70 dB SPL. | Participants with normal hearing were only tested unaided. Participants with hearing loss were tested unaided, 4 channels with fast compression, and 16 channels with fast compression. Fast compression with 4 and 16 channels were assessed to assess the potential role of changes in spectral resolution to changes in speech recognition between these two conditions. | Posted | Mean | Standard Deviation | dB | Each test was approximately 10 minutes and was completed after each experimental manipulation |
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|
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| Secondary | Working Memory | Measure of working memory (correctly repeated words from the reading span test). The minimum (poorer) and maximum (better) values are 0 and 57, respectively. | Posted | Mean | Standard Deviation | score on a scale | Each test was approximately 30 minutes and was completed only once per subject. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Normal Hearing | Group of participants with normal hearing that serve as the reference group. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 4 channels |
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| 16 channels |
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| .062 |
Due to Levene's Test for Equality of Variances, equal variances were not assumed. |
| Superiority |