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Clinical Trials/NCT03511417
NCT03511417WithdrawnNot Applicable

Aging and Speech Perception in Complex Listening Environments

University of Massachusetts, Amherst1 site in 1 countryStarted: October 16, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Speech Perception

Study Overview

Brief Summary

The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. When faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.

Detailed Description

The field trials in this project will require you to use OTC hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. Each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). You will return to the lab for assessment every 2 weeks. During each visit, speech perception and subjective listening effort will be assessed. Depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age 40-64 years
  • •Mild to moderate high frequency hearing loss
  • •Learned English as a first language

Exclusion Criteria

  • •Previous use of hearing aids
  • •Hearing loss/problems attributed to factors other than aging
  • •History of: neurologic disorder, middle-ear disease
  • •Score of < 26 on the Montreal Cognitive Assessment

Arms & Interventions

Middle-aged adults

Experimental

Participants will use an over-the-counter hearing device in one ear until asymptotic speech perception performance is noted (maximum 12 weeks). The same individuals will use over-the-counter hearing devices in each ear until asymptotic performance is noted (the order of these two phases will be randomized across participants). They will be asked to use these devices at least 4 hours/day.

Intervention: over-the-counter hearing device (Device)

Outcomes

Primary Outcomes

Speech Perception

Time Frame: every two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to understand sentences presented in background noise

Localization Ability

Time Frame: every two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to indicate where a sound is coming from when presented in background noise

Cognitive Load

Time Frame: every two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to remember speech that has previously been presented in background noise

Self-Perceived Listening Effort

Time Frame: every two weeks until asymptotic performance is noted (up to 12 weeks)

Changes in how difficult it is to understand speech in background noise

Secondary Outcomes

  • Overall perceived benefit from hearing device(every two weeks until asymptotic performance is noted (up to 12 weeks))
  • Self-perceived hearing device benefit(daily during field trial (up to 12 weeks))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karen Helfer

Professor and Chair

University of Massachusetts, Amherst

Study Sites (1)

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