Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00261768|
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : March 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|Sensorineural Hearing Loss||Behavioral: Digital noise reduction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Noise reduction on
Behavioral: Digital noise reduction
- Words in Noise Test [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|