Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial|
- Words in Noise Test [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261768
|United States, Florida|
|VA Medical Center, Bay Pines|
|Bay Pines, Florida, United States, 33708|
|United States, Tennessee|
|James H. Quillen VA Medical Center|
|Mountain Home, Tennessee, United States, 37684|
|Principal Investigator:||Richard Wilson, PhD||James H. Quillen VA Medical Center|