Supplementing Hearing Aids With Computerized Auditory Training
LACE
1 other identifier
interventional
279
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 13, 2015
CompletedJuly 18, 2018
June 1, 2018
2.2 years
July 30, 2008
October 22, 2014
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Secondary Outcomes (2)
Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Hearing Handicap Inventory for the Elderly (HHI) Change
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Study Arms (4)
LACE-DVD
EXPERIMENTALParticipants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode
LACE-COMPUTER
EXPERIMENTALParticipants will complete a computer-based auditory training program (i.e., LACE)
PLACEBO-DIRECTED LISTENING
ACTIVE COMPARATORParticipants will complete a directed listening to books on CD treatment
CONTROL
ACTIVE COMPARATORParticipants will be provided with hearing aids
Interventions
Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along
No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- known neurological, psychiatric disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708, United States
Related Publications (2)
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).
PMID: 24018575BACKGROUNDSaunders 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.
PMID: 26901263RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel McArdle
- Organization
- Department of Veterans Affairs
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Chisolm, PhD
University of South Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 4, 2008
Study Start
January 1, 2009
Primary Completion
April 1, 2011
Study Completion
December 1, 2011
Last Updated
July 18, 2018
Results First Posted
January 13, 2015
Record last verified: 2018-06