Supplementing Hearing Aids With Computerized Auditory Training (LACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00727337
First received: July 30, 2008
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

The study is designed to examine the effectiveness of a computer-based auditory training program to improve the benefits received by individuals who wear hearing aids. The study will involve 3 groups - a computer-based training group, an active listening group which will involve listening to books on CD, and a placebo group that receives no additional treatment.


Condition Intervention
Hearing Loss
Behavioral: LACE
Behavioral: Directed listening
Behavioral: Usual care
Behavioral: Auditory Training with DVD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supplementing Hearing Aids With Computerized Auditory Training

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Quick Speech in Noise Test [ Time Frame: This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abbreviated Profile of Hearing Aid Benefit [ Time Frame: This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment. ] [ Designated as safety issue: No ]
  • Hearing Handicap Inventory for the Elderly [ Time Frame: This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment. ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Computer-based auditory training
Behavioral: LACE
Computerized Auditory Training
Active Comparator: Arm 2
Directed listening to books on CD
Behavioral: Directed listening
Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along
No Intervention: Arm 3
No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Behavioral: Usual care
No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Experimental: Arm 4
DVD-based auditory training
Behavioral: Auditory Training with DVD
DVD based Auditory Training

Detailed Description:

This proposed study is a multi-site, single-masked (blinded), randomized controlled, parallel group clinical trial to assess the effectiveness of an at home PC-based auditory training as a supplement to standard-of-care hearing-aid intervention in veterans treated for hearing loss, with or without previous hearing-aid experience. The participants will be assigned randomly to one of three groups, with hearing-aid use stratified within the groups: (1) Group 1, HA+AT, in which the participants will receive standard-of-care hearing-aid intervention (HA) and complete the four-week LACE auditory training program (AT); (2) Group 2, HA, with the participants receiving only standard-of-care hearing-aid intervention (HA); and (3) Group 3, HA+DL, in which the participants will receive standard-of-care hearing-aid intervention (HA) and complete four-weeks of placebo auditory training, consisting of directed listening (DL) to books-on-tape. The participants in each group will attend four test sessions. During Session 1 the informed consent process will be completed, baseline assessments will be made to ensure that the participants meet the study inclusion criteria (page 52), testing of predictor variables (page 57-58) will be completed, and all hearing aids will be assessed for correct functionality (page 53). The participants then will be assigned randomly to a study group. Session 2 will occur four weeks after Session 1. During Session 2, baseline performance on the outcome measures will be assessed (page 54-57), as will performance on the predictor variables. Following testing, the participants in Groups 1 and 3 will receive training in the use of the AT or DL programs. Session 3 will occur at the end of the 4-week experimental training period. During Session 3 all participants will be retested on the outcome measures to assess short-term intervention outcomes. During Session 4, which will occur at seven-months post-study enrollment (i.e., six-months post training completion for Groups 1 and 3), all participants will be retested on all outcome measures to examine the long-term outcomes. In Sessions 2-4, the stability of hearing-aid function will be assessed through electroacoustic measures.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. adult onset hearing loss,
  2. English as the first language,
  3. bilateral, symmetric, sensorineural hearing loss,
  4. average audiometric thresholds for 500, 1000, and 2000 Hz less than 50-dB HL in either ear,
  5. aided speech recognition in quiet of 40% binaurally,
  6. appropriate cognitive skills assessed using the Mini Mental State Exam (Folstein et al., 1975) with age/education norms (Crum et al., 1993),
  7. adequate vision to participate in the study as determined with the Smith-Kettlewell Institute Low Luminance (SKILL) Card,
  8. eligible for VA-issued hearing aids.

Exclusion Criteria:

known neurological, psychiatric disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727337

Locations
United States, Florida
VA Medical Center, Bay Pines
Bay Pines, Florida, United States, 33708
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Investigators
Principal Investigator: Theresa Chisolm, PhD VA Medical Center, Bay Pines
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727337     History of Changes
Other Study ID Numbers: C6303-R
Study First Received: July 30, 2008
Last Updated: April 9, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
auditory perception
rehabilitation of hearing impaired

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

ClinicalTrials.gov processed this record on August 28, 2014