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Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Primary Purpose

Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital noise reduction
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Aging, hearing aids, hearing loss, sensorineural, speech recognition

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult onset sensorineural hearing loss English as the first language bilateral symmetrical sensorineural hearing loss Patient is a candidate for directional microphone technology. average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than 25-dB HL in either ear. no history of hearing aid use in the past 10 years appropriate cognitive skills to participate in the study as determined by a passing score on the Mini Mental Scale. Patient has a local telephone and address. Exclusion Criteria: evidence of outer ear, middle ear, or retrocochlear pathology any threshold from 500 to 2000 Hz exceeds 70-dB HL known neurological or psychiatric disorders as determined by chart review known comorbid diseases that would prevent completion of the study as determined by chart review visual impairment that would interfere with reading the questionnaires

Sites / Locations

  • VA Medical Center, Bay Pines
  • James H. Quillen VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Noise reduction on

Outcomes

Primary Outcome Measures

Words in Noise Test

Secondary Outcome Measures

Full Information

First Posted
December 1, 2005
Last Updated
March 19, 2010
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00261768
Brief Title
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
Official Title
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see if noise reduction programs in digital hearing aids help patients hear better than hearing aids without these programs. We also want to know if we can predict how successful patients will be with hearing aids.
Detailed Description
The first goal of this project is to examine the efficacy of digital hearing aids incorporating three noise reduction strategies (i.e., directional microphones alone vs. directional microphones with DSP noise reduction algorithm 1 vs. directional microphones with DSP noise reduction algorithm 2) in terms of both speech understanding outcomes and functional outcomes. The second goal is to identify individual characteristics that are predictive of successful functional outcomes with hearing aids. This study employs a multi-site, randomized, blinded, 2x2 factorial parallel group design. Three hundred subjects will be studied at three VA Medical Centers (Mountain Home, TN; Bay Pines, FL; and Los Angeles, CA) over a period of three years. Objective (word recognition ability and performance with degraded speech stimuli) subjective (self-assessment questionnaires, personality and depression assessments) and cost-effectiveness assessments will be measured for 4 randomized treatment groups receiving different digital hearing aid technology. Subjects will be randomly assigned to wear hearing aids with directional microphones alone or directional microphones with noise reduction algorithm 1 or directional microphones with noise reduction algorithm 2 for a period of 8 weeks. Subjects will complete post-testing after 8 weeks of hearing aid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
Aging, hearing aids, hearing loss, sensorineural, speech recognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Noise reduction on
Intervention Type
Behavioral
Intervention Name(s)
Digital noise reduction
Primary Outcome Measure Information:
Title
Words in Noise Test
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult onset sensorineural hearing loss English as the first language bilateral symmetrical sensorineural hearing loss Patient is a candidate for directional microphone technology. average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than 25-dB HL in either ear. no history of hearing aid use in the past 10 years appropriate cognitive skills to participate in the study as determined by a passing score on the Mini Mental Scale. Patient has a local telephone and address. Exclusion Criteria: evidence of outer ear, middle ear, or retrocochlear pathology any threshold from 500 to 2000 Hz exceeds 70-dB HL known neurological or psychiatric disorders as determined by chart review known comorbid diseases that would prevent completion of the study as determined by chart review visual impairment that would interfere with reading the questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Wilson, PhD
Organizational Affiliation
James H. Quillen VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bay Pines
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
James H. Quillen VA Medical Center
City
Mountain Home
State/Province
Tennessee
ZIP/Postal Code
37684
Country
United States

12. IPD Sharing Statement

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Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

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