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Supplementing Hearing Aids With Computerized Auditory Training (LACE)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LACE-computer
PLACEBO-Directed listening
CONTROL
Lace-DVD
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring auditory perception, rehabilitation of hearing impaired

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • VA Medical Center, Bay Pines

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

LACE-DVD

LACE-COMPUTER

PLACEBO-DIRECTED LISTENING

CONTROL

Arm Description

Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode

Participants will complete a computer-based auditory training program (i.e., LACE)

Participants will complete a directed listening to books on CD treatment

Participants will be provided with hearing aids

Outcomes

Primary Outcome Measures

Words-in-Noise Test (WIN) Change
Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.

Secondary Outcome Measures

Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
The Abbreviated Profile of Hearing Aid Performance (APHAP; Cox & Alexander 1995) was used to assess activity limitations and the Hearing Handicap Inventory for the Elderly or Adults (HHI; Ventry & Weinstein 1982; Newman et al. 1990) was used to assess participation restrictions. The APHAP is a 24-item questionnaire that documents hearing difficulties in specified listening situations. The items are answered on a 7-point scale from 'Always' (or 99%) to 'Never' (or 1%) with higher scores indicating greater reported hearing difficulty. The APHAP global score that ranges from 1 to 99 was used for all analyses.
Hearing Handicap Inventory for the Elderly (HHI) Change
The HHI is a 25-item questionnaire that assesses the social and emotional consequences of hearing loss. The HHI for the elderly is for individuals age 65 years and older (Ventry & Weinstein 1982); the HHI for adults is for individuals aged 64 years and younger (Newman et al. 1990). The versions differ in the wording of three questions. The participants were asked to complete the appropriate HHI for aided listening to reflect their residual hearing handicap. HHI items are answered on a scale of Yes (4 points), Sometimes (2 points) and No (0 points), with higher scores indicating greater reported hearing handicap. Total HHI scores, which can range from 0 to 100, were used for all analyses.

Full Information

First Posted
July 30, 2008
Last Updated
June 20, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00727337
Brief Title
Supplementing Hearing Aids With Computerized Auditory Training
Acronym
LACE
Official Title
Supplementing Hearing Aids With Computerized Auditory Training
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
auditory perception, rehabilitation of hearing impaired

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LACE-DVD
Arm Type
Experimental
Arm Description
Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode
Arm Title
LACE-COMPUTER
Arm Type
Experimental
Arm Description
Participants will complete a computer-based auditory training program (i.e., LACE)
Arm Title
PLACEBO-DIRECTED LISTENING
Arm Type
Active Comparator
Arm Description
Participants will complete a directed listening to books on CD treatment
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Participants will be provided with hearing aids
Intervention Type
Behavioral
Intervention Name(s)
LACE-computer
Intervention Description
Computerized Auditory Training
Intervention Type
Behavioral
Intervention Name(s)
PLACEBO-Directed listening
Intervention Description
Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along
Intervention Type
Behavioral
Intervention Name(s)
CONTROL
Intervention Description
No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Intervention Type
Behavioral
Intervention Name(s)
Lace-DVD
Intervention Description
DVD based Auditory Training
Primary Outcome Measure Information:
Title
Words-in-Noise Test (WIN) Change
Description
Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.
Time Frame
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Secondary Outcome Measure Information:
Title
Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
Description
The Abbreviated Profile of Hearing Aid Performance (APHAP; Cox & Alexander 1995) was used to assess activity limitations and the Hearing Handicap Inventory for the Elderly or Adults (HHI; Ventry & Weinstein 1982; Newman et al. 1990) was used to assess participation restrictions. The APHAP is a 24-item questionnaire that documents hearing difficulties in specified listening situations. The items are answered on a 7-point scale from 'Always' (or 99%) to 'Never' (or 1%) with higher scores indicating greater reported hearing difficulty. The APHAP global score that ranges from 1 to 99 was used for all analyses.
Time Frame
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Title
Hearing Handicap Inventory for the Elderly (HHI) Change
Description
The HHI is a 25-item questionnaire that assesses the social and emotional consequences of hearing loss. The HHI for the elderly is for individuals age 65 years and older (Ventry & Weinstein 1982); the HHI for adults is for individuals aged 64 years and younger (Newman et al. 1990). The versions differ in the wording of three questions. The participants were asked to complete the appropriate HHI for aided listening to reflect their residual hearing handicap. HHI items are answered on a scale of Yes (4 points), Sometimes (2 points) and No (0 points), with higher scores indicating greater reported hearing handicap. Total HHI scores, which can range from 0 to 100, were used for all analyses.
Time Frame
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult onset hearing loss, English as the first language, bilateral, symmetric, sensorineural hearing loss, average audiometric thresholds for 500, 1000, and 2000 Hz less than 50-dB HL in either ear, aided speech recognition in quiet of 40% binaurally, appropriate cognitive skills assessed using the Mini Mental State Exam (Folstein et al., 1975) with age/education norms (Crum et al., 1993), adequate vision to participate in the study as determined with the Smith-Kettlewell Institute Low Luminance (SKILL) Card, 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Chisolm, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bay Pines
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24018575
Citation
Chisolm TH, Saunders GH, Frederick MT, McArdle RA, Smith SL, Wilson RH. Learning to listen again: the role of compliance in auditory training for adults with hearing loss. Am J Audiol. 2013 Dec;22(2):339-42. doi: 10.1044/1059-0889(2013/12-0081).
Results Reference
background
PubMed Identifier
26901263
Citation
Saunders GH, Smith SL, Chisolm TH, Frederick MT, McArdle RA, Wilson RH. A Randomized Control Trial: Supplementing Hearing Aid Use with Listening and Communication Enhancement (LACE) Auditory Training. Ear Hear. 2016 Jul-Aug;37(4):381-96. doi: 10.1097/AUD.0000000000000283.
Results Reference
result

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Supplementing Hearing Aids With Computerized Auditory Training

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