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Variability In Hearing Aid Outcomes In Older Adults

NCT ID: NCT02448706

Last Updated: 2020-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-07-31

Brief Summary

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The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.

Detailed Description

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Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.

Conditions

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Hearing Loss Presbycusis

Keywords

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hearing aid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hearing Aid Fitting Order A

High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.

Group Type ACTIVE_COMPARATOR

Hearing Aid Fitting A

Intervention Type DEVICE

Hearing Aid Fitting B

Intervention Type DEVICE

Hearing Aid Fitting Order B

Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.

Group Type ACTIVE_COMPARATOR

Hearing Aid Fitting A

Intervention Type DEVICE

Hearing Aid Fitting B

Intervention Type DEVICE

Interventions

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Hearing Aid Fitting A

Intervention Type DEVICE

Hearing Aid Fitting B

Intervention Type DEVICE

Other Intervention Names

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Hearing Aid

Eligibility Criteria

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Inclusion Criteria

* Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL
* Non hearing aided wearer within the previous year
* Participants will be in good health (self-report)
* Normal or corrected to normal vision(≤20/50)

Exclusion Criteria

* Conductive, or asymmetric hearing loss
* Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
* Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
* Significant history of otologic or neurologic disorders
* Non English speaking participants
* Score of 23 or below on Mini-Mental Status Exam (MMSE)
* Score of 22 or below on Montreal Cognitive Assessment (MoCA)
* Any clinically significant unstable or progressive medical condition
* Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
* Participants will be divided into low and high working groups based upon the results of their Lunner working memory reading span test. Once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.
Minimum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Pamela Souza

Professor School of Communication

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela E Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Kathryn H Arehart, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado at Boulder

Locations

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University of Colorado at Boulder

Boulder, Colorado, United States

Site Status

Countries

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United States

References

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Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. Int J Audiol. 2018 Nov;57(11):809-815. doi: 10.1080/14992027.2018.1490035. Epub 2018 Jul 27.

Reference Type DERIVED
PMID: 30052097 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

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Other Identifiers

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1R01DC012289-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R01DC012289-01

Identifier Type: NIH

Identifier Source: org_study_id

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