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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DC012289-01 | 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 goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.
Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Aid Fitting Order A | Active Comparator | High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. |
|
| Hearing Aid Fitting Order B | Active Comparator | Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid Fitting A | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility Score | Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Aural Rehabilitation (EAR) | The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved). | 6 weeks |
| Speech and Spatial Qualities of Hearing (SSQ) Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela E Souza, PhD | Northwestern University | Principal Investigator |
| Kathryn H Arehart, PhD | University of Colorado at Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado at Boulder | Boulder | Colorado | 80309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30052097 | Derived | Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. Int J Audiol. 2018 Nov;57(11):809-815. doi: 10.1080/14992027.2018.1490035. Epub 2018 Jul 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hearing Aid Fitting Order A | High level of signal manipulation (5 weeks), then low level of signal manipulation (5 weeks) |
| FG001 | Hearing Aid Fitting Order B | Low level of signal manipulation (5 weeks), then high level of signal manipulation (5 weeks) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants received the same baseline measures, regardless of the hearing aid fitting order to which they were randomized |
| 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 | Speech Intelligibility Score | Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words. | Posted | Mean | Standard Deviation | percentage of correct responses | 6 weeks |
|
12 weeks
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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 Fitting A | High level of signal manipulation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Souza | Northwestern University | 8474912433 | p-souza@northwestern.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 1, 2019 | Sep 5, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2020 | Oct 23, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D011304 | Presbycusis |
| 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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| Hearing Aid Fitting B | Device |
|
Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
| 6 weeks |
| Adherence | Average number of hours per day the hearing aid was worn. | 6 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Reading span task | Participants view a series of sentences on a computer screen. For each sentence, participants are asked to make a judgment as to whether the sentence makes semantic sense (processing task). After a block of sentences, the participant is asked to recall either first of last words of the sentences (storage task). Final score is the percentage of correctly recalled words. | Mean | Full Range | percentage of correctly recalled words |
|
|
|
| Secondary | Effectiveness of Aural Rehabilitation (EAR) | The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved). | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Secondary | Speech and Spatial Qualities of Hearing (SSQ) Questionnaire | Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Secondary | Adherence | Average number of hours per day the hearing aid was worn. | Posted | Mean | Standard Deviation | hours per day | 6 weeks |
|
|
|
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Hearing Aid Fitting B | Low level of signal manipulation | 0 | 49 | 0 | 49 | 0 | 49 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006319 | Hearing Loss, Sensorineural |