NCT Number: NCT00261768
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
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.
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Notify MeKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
VA Medical Center, Bay Pines, Bay Pines, Florida, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Words in Noise Test
Time frame: 2 months
Sponsors and collaborators
Lead sponsor
US Department of Veterans Affairs
Fed
Registry information
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Dec 5, 2005
- Registry last updated
- Mar 23, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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