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| Name | Class |
|---|---|
| Hearts for Hearing | OTHER |
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Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants with bilateral moderate to severe sensorineural hearing loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roger microphone | Device | Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility in Noise | The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented. | Day 1 of a one day study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearts for Hearing | Oklahoma City | Oklahoma | 73120 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Participants with bilateral moderate to severe sensorineural hearing loss Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Participants with bilateral moderate to severe sensorineural hearing loss Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid |
| Units | Counts |
|---|---|
| Participants |
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| 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 in Noise | The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Day 1 of a one day study |
|
One day
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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 | Experimental | Participants with bilateral moderate to severe sensorineural hearing loss Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Audiologist | Sonova USCS | 630-821-5000 | phonakaudiologyresearch@gmail.com |
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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 | Nov 26, 2021 | Oct 20, 2022 | 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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| Phonak Audeo hearing aid | Device | Commercially available receiver-in-canal hearing aid |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Bilateral Moderate to Severe Sensorineural Hearing Loss | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |