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Supplementing Hearing Aids With Computerized Auditory Training (LACE)

This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, July 2008

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727337
  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

Genetics Home Reference related topics:   nonsyndromic deafness   

MedlinePlus related topics:   Hearing Disorders and Deafness   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Supplementing Hearing Aids With Computerized Auditory Training

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 ]

Estimated Enrollment:   288
Study Start Date:   October 2008
Estimated Study Completion Date:   June 2011
Estimated Primary Completion Date:   September 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Computer-based auditory training
Behavioral: LACE
Computerized Auditory Training
2: Active Comparator
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
3: Placebo Comparator
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

Detailed Description:

This proposed study will be 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:

The participants will be recruited from the VA Medical Centers at Bay Pines, FL; Mountain Home, TN, and Portland, OR. Inclusion criteria consist of:

  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. no known neurological, psychiatric disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,
  8. adequate vision to participate in the study as determined with the Smith-Kettlewell Institute Low Luminance (SKILL) Card,
  9. eligible for VA-issued hearing aids.

Exclusion Criteria:

  Contacts and Locations

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

Contacts
Contact: Cassie Eiffert     (727) 398-6661 ext 4862     cassie.eiffert@va.gov    

Locations
United States, Florida
VA Medical Center, Bay Pines     Not yet recruiting
      Bay Pines, Florida, United States, 33708
      Contact: Cassie Eiffert     727-398-6661 ext 4862     cassie.eiffert@va.gov    
      Principal Investigator: Theresa Chisolm, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Theresa Chisolm, PhD     VA Medical Center, Bay Pines    
  More Information


Responsible Party:   Department of Veterans Affairs ( Chisolm, Theresa - Principal Investigator )
Study ID Numbers:   C6303R
First Received:   July 30, 2008
Last Updated:   August 1, 2008
ClinicalTrials.gov Identifier:   NCT00727337
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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