Clinical trial NCT00727337: Supplementing Hearing Aids With Computerized Auditory Training
Official title: Supplementing Hearing Aids With Computerized Auditory Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: auditory perception
rehabilitation of hearing impaired
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-08-04
Enrollment: 279
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Words-in-Noise Test (WIN) Change
timeFrame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Secondary outcomes:
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
timeFrame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
measure: Hearing Handicap Inventory for the Elderly (HHI) Change
timeFrame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: VA Medical Center, Bay Pines
state: Florida
Study officials:
affiliation: University of South Florida
name: Theresa Chisolm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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).
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.