Variability In Hearing Aid Outcomes In Older Adults

October 23, 2020 updated by: Pamela Souza, Northwestern University

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado at Boulder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

54 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hearing Aid Fitting Order A
High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Device: Hearing Aid Fitting A
Other Names:
  • Hearing Aid
Device: Hearing Aid Fitting B
Active Comparator: Hearing Aid Fitting Order B
Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Device: Hearing Aid Fitting A
Other Names:
  • Hearing Aid
Device: Hearing Aid Fitting B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Intelligibility Score
Time Frame: 6 weeks
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Aural Rehabilitation (EAR)
Time Frame: 6 weeks
The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).
6 weeks
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
Time Frame: 6 weeks
Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
6 weeks
Adherence
Time Frame: 6 weeks
Average number of hours per day the hearing aid was worn.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Pamela E Souza, PhD, Northwestern University
  • Principal Investigator: Kathryn H Arehart, PhD, University of Colorado at Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DC012289-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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