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Auditory Training and Hearing Aid Satisfaction (ATandHAs)

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ClinicalTrials.gov Identifier: NCT04230876
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Hearing Impairment, Sensorineural Behavioral: Auditory Brian Training Games/Activities Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
Masking: Single (Participant)
Masking Description: Participants are unaware if they are in the late or early intervention group.
Primary Purpose: Health Services Research
Official Title: Auditory Brain Training to Enhance Satisfaction and Usage of New Hearing Aids by Older Adults
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids


Intervention Details:
  • Behavioral: Auditory Brian Training Games/Activities
    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 Measures :
  1. Change in Hearing Aid Satisfaction After Auditory Training [ Time Frame: Three weeks after hearing aid fitting and after completing the four week training protocol. ]
    The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a start value, but positive values between one and three indicate improvement.

  2. Change in Hearing Aid Satisfaction After Auditory Training [ Time Frame: Three weeks after hearing aid fitting and after completing the four week training protocol. ]
    The International Outcome Inventory for Hearing Aids (IOI-HA) is a hearing aid satisfaction questionnaire that uses series of seven Questions on a five-point scale (0-5 points possible points of improvement).

  3. Change in Hearing Aid Satisfaction After Auditory Training [ Time Frame: Three weeks after hearing aid fitting and after completing the four week training protocol. ]
    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 (0-7 points possible points of improvement).

  4. Change in Hearing Aid Satisfaction After Auditory Training [ Time Frame: Three weeks after hearing aid fitting and after completing the four week training protocol. ]
    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 on a 10-point (0-10 points possible points of improvement).

  5. Change in Hearing Aid Satisfaction After Auditory Training [ Time Frame: Three weeks after hearing aid fitting and after completing the four week training protocol. ]
    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 :
  1. Change in Percent Words Correct on Speech Perception Measures after Auditory Training [ Time Frame: At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol. ]
    Standard clinical assessments of word perception with the hearing aid.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230876


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 62220
Sponsors and Collaborators
Washington University School of Medicine
National Institute on Aging (NIA)
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04230876    
Other Study ID Numbers: 201909043
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data collected are to be used exclusively by research team and clEAR.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Auditory Training
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases