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Auditory Training and Hearing Aid Satisfaction (ATandHAs)

Primary Purpose

Hearing Impairment, Sensorineural

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Auditory Brian Training Games/Activities
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Impairment, Sensorineural focused on measuring Auditory Training

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be a native English speaker
  • Must have a mild to severe bilateral sensorineural hearing loss
  • Must be a candidate for new hearing aid(s) (have never used hearing aids)

Exclusion Criteria:

  • Cognitive impairment or any factors that would prohibit a participant from completing questionnaires
  • Cognitive or speech production factors that would prohibit a participant from repeating words during a speech perception test.

Sites / Locations

  • Washington University School of Medicine

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 10, 2020
Last Updated
August 24, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04230876
Brief Title
Auditory Training and Hearing Aid Satisfaction
Acronym
ATandHAs
Official Title
Auditory Brain Training to Enhance Satisfaction and Usage of New Hearing Aids by Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment, Sensorineural
Keywords
Auditory Training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
Masking
Participant
Masking Description
Participants are unaware if they are in the late or early intervention group.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Auditory Brian Training Games/Activities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hearing Aid Satisfaction After Auditory Training
Description
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.
Time Frame
Three weeks after hearing aid fitting and after completing the four week training protocol.
Title
Change in Hearing Aid Satisfaction After Auditory Training
Description
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.
Time Frame
Three weeks after hearing aid fitting and after completing the four week training protocol.
Title
Change in Hearing Aid Satisfaction After Auditory Training
Description
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.
Time Frame
Three weeks after hearing aid fitting and after completing the four week training protocol.
Title
Change in Hearing Aid Satisfaction After Auditory Training
Description
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.
Time Frame
Three weeks after hearing aid fitting and after completing the four week training protocol.
Title
Change in Hearing Aid Satisfaction After Auditory Training
Description
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.
Time Frame
Three weeks after hearing aid fitting and after completing the four week training protocol.
Secondary Outcome Measure Information:
Title
Change in Percent Words Correct on Speech Perception Measures After Auditory Training
Description
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.
Time Frame
At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be a native English speaker Must have a mild to severe bilateral sensorineural hearing loss Must be a candidate for new hearing aid(s) (have never used hearing aids) Exclusion Criteria: Cognitive impairment or any factors that would prohibit a participant from completing questionnaires Cognitive or speech production factors that would prohibit a participant from repeating words during a speech perception test.
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
62220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data collected are to be used exclusively by research team and clEAR.

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Auditory Training and Hearing Aid Satisfaction

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