NCT00371839

Brief Summary

The purpose of this study is to determine the effects of age-related cognitive changes on hearing aid benefit based on hearing aid compression time constants. The hypothesis is that people with poor working memory skills will benefit from slow time constants in hearing aid compression while those with good working memory skills will be able to benefit from more sophisticated compression algorithms with rapid time constants.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 19, 2014

Completed
Last Updated

December 8, 2014

Status Verified

November 1, 2014

Enrollment Period

4.3 years

First QC Date

August 31, 2006

Results QC Date

November 6, 2014

Last Update Submit

November 19, 2014

Conditions

Keywords

Hearing LossHearing AidsRehabilitation of hearing impaired

Outcome Measures

Primary Outcomes (1)

  • Ability to Understand Speech in Noise Background

    Measure speech perception for sentences in background noise

    one year

Study Arms (3)

Mild Hearing Loss

ACTIVE COMPARATOR

Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)

Procedure: Audiological Evaluation

Moderate Hearing Loss

ACTIVE COMPARATOR

Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)

Procedure: Audiological Evaluation

Moderate-Severe Hearing Loss

ACTIVE COMPARATOR

Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)

Procedure: Audiological Evaluation

Interventions

Tests of hearing, cognition, and speech perception

Mild Hearing LossModerate Hearing LossModerate-Severe Hearing Loss

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be 50 to 75 years old.
  • Hearing loss will be limited to 40 dB HL from 250 Hz through 1000 Hz, and to 60 dB HL through 4000 Hz.
  • Hearing loss must be greater than 25 dB at two or more frequencies from 250 to 4000 Hz.

You may not qualify if:

  • None of the participants will be current or past hearing aid users; all will be free of ear disease.
  • Participants with conductive hearing losses, defined as air-bone gap greater than 15 dB, will be excluded.
  • The audiometric battery with acoustic reflex thresholds and decay measurements will be used to exclude anyone with evidence of a central disorder or a pathology other than a sensorineural loss. Those potential participants will be referred to a medical professional.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Marjorie R. Leek
Organization
Portland VAMC

Study Officials

  • Marjorie R. Leek, PhD

    VA Loma Linda Healthcare System, Loma Linda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

December 8, 2014

Results First Posted

November 19, 2014

Record last verified: 2014-11