Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
NCT ID: NCT00261768
Last Updated: 2010-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
288 participants
INTERVENTIONAL
2004-06-30
2006-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Noise reduction on
Digital noise reduction
Interventions
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Digital noise reduction
Eligibility Criteria
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Inclusion Criteria
2. English as the first language
3. bilateral symmetrical sensorineural hearing loss
4. Patient is a candidate for directional microphone technology.
5. average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than 25-dB HL in either ear.
6. no history of hearing aid use in the past 10 years
7. appropriate cognitive skills to participate in the study as determined by a passing score on the Mini Mental Scale.
8. Patient has a local telephone and address.
Exclusion Criteria
2. any threshold from 500 to 2000 Hz exceeds 70-dB HL
3. known neurological or psychiatric disorders as determined by chart review
4. known comorbid diseases that would prevent completion of the study as determined by chart review
5. visual impairment that would interfere with reading the questionnaires
18 Years
85 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Department of Veterans Affairs
Principal Investigators
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Richard Wilson, PhD
Role: PRINCIPAL_INVESTIGATOR
James H. Quillen VA Medical Center
Locations
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VA Medical Center, Bay Pines
Bay Pines, Florida, United States
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States
Countries
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Other Identifiers
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C3011R
Identifier Type: -
Identifier Source: org_study_id
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