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Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261768
First Posted: December 5, 2005
Last Update Posted: March 23, 2010
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.
Information provided by:
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Sensorineural Hearing Loss Behavioral: Digital noise reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Words in Noise Test [ Time Frame: 2 months ]

Enrollment: 288
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Noise reduction on
Behavioral: Digital noise reduction

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Richard Wilson, PhD James H. Quillen VA Medical Center
  More Information

Responsible Party: Wilson, Richard - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00261768     History of Changes
Other Study ID Numbers: C3011R
First Submitted: December 1, 2005
First Posted: December 5, 2005
Last Update Posted: March 23, 2010
Last Verified: March 2010

Keywords provided by VA Office of Research and Development:
Aging
hearing aids
hearing loss, sensorineural
speech recognition

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms