Supplementing Hearing Aids With Computerized Auditory Training

NCT ID: NCT00727337

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LACE-DVD

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

Group Type: EXPERIMENTAL

Lace-DVD

Intervention Type: BEHAVIORAL

DVD based Auditory Training

LACE-COMPUTER

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

Group Type: EXPERIMENTAL

LACE-computer

Intervention Type: BEHAVIORAL

Computerized Auditory Training

PLACEBO-DIRECTED LISTENING

Participants will complete a directed listening to books on CD treatment

Group Type: ACTIVE_COMPARATOR

PLACEBO-Directed listening

Intervention Type: BEHAVIORAL

Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along

CONTROL

Participants will be provided with hearing aids

Group Type: ACTIVE_COMPARATOR

CONTROL

Intervention Type: BEHAVIORAL

No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids

Interventions

LACE-computer

Computerized Auditory Training

Intervention Type: BEHAVIORAL

PLACEBO-Directed listening

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

CONTROL

No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids

Intervention Type: BEHAVIORAL

Lace-DVD

DVD based Auditory Training

Intervention Type: BEHAVIORAL

Eligibility 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,

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Chisolm, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

VA Medical Center, Bay Pines

Bay Pines, Florida, United States

Countries

United States

References

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).

Reference Type: BACKGROUND

PMID: 24018575 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26901263 (View on PubMed)

Other Identifiers

C6303-R

Identifier Type: -

Identifier Source: org_study_id