Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00261768
First received: December 1, 2005
Last updated: March 19, 2010
Last verified: March 2010

December 1, 2005
March 19, 2010
June 2004
December 2006   (final data collection date for primary outcome measure)
Words in Noise Test [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • babble.
  • All outcomes will be measured at a baseline visit, and repeated 8 weeks post-treatment.
  • 1. Change in the Profile of Hearing Aid Benefit score. 2. Change in word recognition score in multitalker
  • 3. Change in the Satisfaction with Daily Life score.
  • 4. Change in the Communication Profile for the Hearing
  • Impaired score.
Complete list of historical versions of study NCT00261768 on ClinicalTrials.gov Archive Site
Not Provided
1. Change in the MOS SF36V score between baseline and 8 weeks post intervention.
Not Provided
Not Provided
 
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Sensorineural Hearing Loss
Behavioral: Digital noise reduction
Experimental: 1
Noise reduction on
Intervention: Behavioral: Digital noise reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. adult onset sensorineural hearing loss
  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:

  1. evidence of outer ear, middle ear, or retrocochlear pathology
  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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00261768
C3011R
Yes
Wilson, Richard - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Richard Wilson, PhD James H. Quillen VA Medical Center
Department of Veterans Affairs
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP