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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Although hearing aids are the most common treatment for hearing loss, and have the potential to help seniors stay active and productive, almost 50% of them who receive hearing aids rarely if ever use them, a state of affairs sometimes referred to as "the hearing aid in the drawer" syndrome. clEAR's customized auditory brain training has been shown to be effective in improving adults' abilities to recognize speech, in reducing their perceptual effort associated with listening with a hearing loss, and in increasing their confidence to engage in everyday conversations. In the proposed research, we will determine whether older adults who receive hearing aids for the first time report higher satisfaction with their new hearing aids and have longer daily use time as a result of having completed clEAR's auditory brain training program for new hearing aid users.
Auditory training as the potential to dramatically affect older persons' adjustment to a new hearing aid and to maximize the benefits they receive from wearing one. In turn, by wearing hearing aids, they experience easier and more successful communication patterns. They enhance their ability to engage in everyday conversations and will be able to become more socially involved with their family and friends. In this study we will try to determine the extent to which web-based clEAR auditory brain training, with concomitant support from a clEAR in-house audiologist, affects satisfaction with new hearing aids and increases daily use time. The study will include thirty adults over the age of 60 years who have received hearing aids for the first time. After an adjustment period, half will complete clEAR's auditory brain training program right away and the other half will complete it after a delay period, and both will complete a control condition. To establish the level of feasibility and clinical utility. We will measure hearing aid satisfaction, benefit ratings, and hearing aid use time.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory Brian Training Games/Activities | Behavioral | Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently received new hearing aids. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing Aid Satisfaction After Auditory Training | The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. | Three weeks after hearing aid fitting and after completing the four week training protocol. |
| Change in Hearing Aid Satisfaction After Auditory Training | The International Outcome Inventory for Hearing Aids (IOI-HA) is a hearing aid satisfaction questionnaire that averages a series of seven questions on a five-point scale (0-5 possible points of improvement). IOI-HA scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. Higher values between 1 and 5 indicate more relative satisfaction. | Three weeks after hearing aid fitting and after completing the four week training protocol. |
| Change in Hearing Aid Satisfaction After Auditory Training | Abbreviated Profile of Hearing Aid Benefit (APHAB) is common clinical questionnaire for determining hearing aid benefit using a series of 24 questions on a seven-point scale (A-G; the scale is then converted to "percent of time" from 1% (Never) to 99% (Always) and 50% means half of the time). Hearing aid benefit is calculated as the difference between the performance with a hearing and and performance without a hearing aid. More positive values indicate more benefit. | Three weeks after hearing aid fitting and after completing the four week training protocol. |
| Change in Hearing Aid Satisfaction After Auditory Training |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Words Correct on Speech Perception Measures After Auditory Training | The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wearing the hearing aid. NU-6 scores are in percent words correctly identified. Scores reported here are the difference between scores measured before and after completing the Amptify DTx. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 62220 | United States |
The data collected are to be used exclusively by research team and clEAR.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amptify First | The Amptify First group received the following order:
|
| FG001 | Amptify Second | The Amptify First group received the following order:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amptify First | The Amptify First group received the following order:
|
| BG001 | Amptify Second |
| 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 | Change in Hearing Aid Satisfaction After Auditory Training | The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. | Posted | Mean | Standard Deviation | units on a scale | Three weeks after hearing aid fitting and after completing the four week training protocol. |
|
10 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 | Amptify First | The Amptify First group received the following order:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Cardinal | Amptify | 3143999940 | Chris@amptify.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2022 | Jul 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2022 | Jul 7, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2020 | Jun 14, 2022 | ICF_002.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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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
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Participants are unaware if they are in the late or early intervention group.
The Speech, Spatial and Qualities of Hearing Scale (SSQ-12) is a subjective tool or assessing the quality of the sound from a hearing aid using a 12-item questionnaire. Questions focus on how well the participant could hear in various situations. The responses range on a scale from "Not At All" (0) to Perfectly (10). Higher values indicate better sound quality. |
| Three weeks after hearing aid fitting and after completing the four week training protocol. |
| Change in Hearing Aid Satisfaction After Auditory Training | Daily use (in hours/day) is logged by the participant. Improvement is indicated by an increase in the amount of time the participant uses the hearing aid each day. | Three weeks after hearing aid fitting and after completing the four week training protocol. |
| At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol. |
The Amptify First group received the following order:
|
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Pure-Tone-Average | Mean | Standard Deviation | Sound Level in dB(HL) |
|
| OG001 | Amptify Second | The Amptify First group received the following order:
|
|
|
|
| Primary | Change in Hearing Aid Satisfaction After Auditory Training | The International Outcome Inventory for Hearing Aids (IOI-HA) is a hearing aid satisfaction questionnaire that averages a series of seven questions on a five-point scale (0-5 possible points of improvement). IOI-HA scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. Higher values between 1 and 5 indicate more relative satisfaction. | Two participants in the Amptify First group and one participant in the Amptify second group did not complete the first IOI-HA questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Three weeks after hearing aid fitting and after completing the four week training protocol. |
|
|
|
|
| Primary | Change in Hearing Aid Satisfaction After Auditory Training | Abbreviated Profile of Hearing Aid Benefit (APHAB) is common clinical questionnaire for determining hearing aid benefit using a series of 24 questions on a seven-point scale (A-G; the scale is then converted to "percent of time" from 1% (Never) to 99% (Always) and 50% means half of the time). Hearing aid benefit is calculated as the difference between the performance with a hearing and and performance without a hearing aid. More positive values indicate more benefit. | Posted | Mean | Standard Deviation | score on a scale | Three weeks after hearing aid fitting and after completing the four week training protocol. |
|
|
|
|
| Primary | Change in Hearing Aid Satisfaction After Auditory Training | The Speech, Spatial and Qualities of Hearing Scale (SSQ-12) is a subjective tool or assessing the quality of the sound from a hearing aid using a 12-item questionnaire. Questions focus on how well the participant could hear in various situations. The responses range on a scale from "Not At All" (0) to Perfectly (10). Higher values indicate better sound quality. | Posted | Mean | Standard Deviation | units on a scale | Three weeks after hearing aid fitting and after completing the four week training protocol. |
|
|
|
|
| Primary | Change in Hearing Aid Satisfaction After Auditory Training | Daily use (in hours/day) is logged by the participant. Improvement is indicated by an increase in the amount of time the participant uses the hearing aid each day. | Posted | Mean | Standard Deviation | hours/day | Three weeks after hearing aid fitting and after completing the four week training protocol. |
|
|
|
|
| Secondary | Change in Percent Words Correct on Speech Perception Measures After Auditory Training | The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wearing the hearing aid. NU-6 scores are in percent words correctly identified. Scores reported here are the difference between scores measured before and after completing the Amptify DTx. | Posted | Mean | Standard Deviation | Percent words correct | At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol. |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Amptify Second | The Amptify First group received the following order:
| 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 |