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| ID | Type | Description | Link |
|---|---|---|---|
| R41DC017939 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Wisconsin, Milwaukee | OTHER |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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Find a personal sound amplification device that can help people hear better.
Personal sound amplification devices (PSADs) have recently become available to the public. PSADs serve a potentially important role in providing audibility of sounds for adults who find themselves having difficulty hearing and understanding speech in some daily living situations, but may not be candidates for traditional, high-amplification hearing aids. Despite hearing loss being a very common problem, few adults who could benefit from some level of amplification actually access the technology. Only approximately 1 in 7 adults (14%) over the age of 50 with a hearing loss using amplification. High cost is the most commonly cited reason for not wanting to try amplification, and indeed, hearing aids range from $1000 to $5000 each (i.e., per ear). PSADs range from $50-$600 each, and may provide a reasonable option for people who are not ready, or are unwilling, to wear a hearing aid. This project aims to examine the feasibility of a PSAD to provide audible and clear sound signal to adult listeners. The significance of this project is its potential to develop an option for individuals to take advantage of amplification and access sound to improve quality of life, who may not otherwise do so without this technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with difficulty hearing in some daily listening situations | Patients listen to sounds with and without the personal sound amplification smartphone application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascending Hearing Technologies device | Device | Personal Sound Amplification Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sentence Perception in Noise Fine-tuned v Unamplified | The fine-tuned Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly. | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
| Sentence Perception in Noise Initial Fit v Unamplified | The prescription gain (initial fit) Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly. | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Words Clear | The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device. The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Higher values mean better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults who report difficulty hearing in some daily listening situations
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| Name | Affiliation | Role |
|---|---|---|
| Christina L Runge, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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Not applicable. Enrollment and subject participation in the experiment occurred sequentially within the same study visit.
Recruitment occurred February through September 2021. Participants were recruited from the audiology and ear nose and throat clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | PSAD | Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PSAD | Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device |
| 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 | Sentence Perception in Noise Fine-tuned v Unamplified | The fine-tuned Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly. | All subjects | Posted | Mean | Standard Deviation | percentage of words heard correctly | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
|
|
90 minutes
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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 | PSAD | Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Runge | Ascending Hearing Technologies, LLC | 2623523478 | chrunge@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 7, 2022 | Nov 22, 2022 | Prot_SAP_ICF_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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| The patient will wear the personal sound amplification device on average for 30 minutes. |
| Sentences Easy to Understand | The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device. The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'sentences were easy to understand.' Higher values mean better outcome. | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
| Sounds Are Distorted | The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Lower values mean better outcome. | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
| Participants |
|
| Age, Continuous | Geometric Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Speech perception percent correct | Speech perception score is calculated as the percent of words heard correctly | Mean | Standard Deviation | percent words correct |
|
| Sound quality: Words were clear | Sound quality was measured using a Likert scale. The Likert rating scale measures the subject's perception of how well she/he heard both with the Personal Sound Amplification Device and without the device. The patient rates the following questions on a scale from Strongly Disagree (value=0), Disagree (value=1), Neutral (value=2), Agree (value=3), and Strongly Agree (value=4) for the statement 'words sounded clear.' Higher values mean better sound quality outcome. | Mean | Standard Deviation | score on a scale |
|
| Sound quality: Sentences were easy to understand | Sound quality was measured using a Likert scale. The Likert rating scale measures the subject's perception of how well she/he heard both with the Personal Sound Amplification Device and without the device. The patient rates the following questions on a scale from Strongly Disagree (value=0), Disagree (value=1), Neutral (value=2), Agree (value=3), and Strongly Agree (value=4) for the statement 'sentences were easy to understand.' Higher values mean better sound quality outcome. | Mean | Standard Deviation | score on a scale |
|
| Sound quality: sounds were distorted | Sound quality was measured using a Likert scale. The Likert rating scale measures the subject's perception of how well she/he heard both with the Personal Sound Amplification Device and without the device. The patient rates the following questions on a scale from Strongly Disagree (value=0), Disagree (value=1), Neutral (value=2), Agree (value=3), and Strongly Agree (value=4) for the statement 'sounds were distorted.' Lower values mean better sound quality outcome. | Mean | Standard Deviation | score on a scale |
|
| Participants |
|
|
| Primary | Sentence Perception in Noise Initial Fit v Unamplified | The prescription gain (initial fit) Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly. | All subjects | Posted | Mean | Standard Deviation | percentage of words heard correctly | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
|
|
|
| Secondary | Words Clear | The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device. The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Higher values mean better outcome. | All subjects | Posted | Mean | Standard Deviation | score on a scale | The patient will wear the personal sound amplification device on average for 30 minutes. |
|
|
|
| Secondary | Sentences Easy to Understand | The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device. The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'sentences were easy to understand.' Higher values mean better outcome. | All subjects | Posted | Mean | Standard Deviation | score on a scale | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
|
|
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| Secondary | Sounds Are Distorted | The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Lower values mean better outcome. | All subjects | Posted | Mean | Standard Deviation | score on a scale | The patient will wear the Personal Sound Amplification Device for approximately 30 minutes |
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| 0 |
| 32 |
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| 32 |
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| 32 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |