Hearing Loss
Conditions
Keywords
auditory perception, rehabilitation of hearing impaired
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.
Interventions
BEHAVIORALLACE-computer
Computerized Auditory Training
BEHAVIORALPLACEBO-Directed listening
Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along
BEHAVIORALCONTROL
No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
BEHAVIORALLace-DVD
DVD based Auditory Training
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Words-in-Noise Test (WIN) Change | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up | 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
| Measure | Time frame | Description |
|---|---|---|
| Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up | 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 | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LACE-DVD DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training | 68 |
| LACE-COMPUTER Computer-based auditory training
LACE: Computerized Auditory Training | 65 |
| PLACEBO-DIRECTED LISTENING Directed listening to books on CD
Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along | 73 |
| CONTROL No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids | 73 |
| Total | 279 |
Baseline characteristics
| Characteristic | LACE-COMPUTER | PLACEBO-DIRECTED LISTENING | LACE-DVD | CONTROL | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 42 Participants | 36 Participants | 40 Participants | 52 Participants | 170 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 37 Participants | 28 Participants | 21 Participants | 109 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 7.8 | 67.1 years STANDARD_DEVIATION 7.7 | 68.2 years STANDARD_DEVIATION 7.7 | 70 years STANDARD_DEVIATION 7.3 | 68.6 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 65 Participants | 73 Participants | 68 Participants | 73 Participants | 279 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 65 Participants | 73 Participants | 68 Participants | 73 Participants | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 65 | 0 / 73 | 0 / 73 |
| serious Total, serious adverse events | 0 / 68 | 0 / 65 | 0 / 73 | 0 / 73 |
Outcome results
Primary
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.
Time frame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Population: Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LACE-DVD | Words-in-Noise Test (WIN) Change | 6 MONTH FOLLOW UP | 9.3 dB SNR | Standard Deviation 2.2 |
| LACE-DVD | Words-in-Noise Test (WIN) Change | POST-INTERVENTION | 9 dB SNR | Standard Deviation 2.3 |
| LACE-DVD | Words-in-Noise Test (WIN) Change | BASELINE | 9.8 dB SNR | Standard Deviation 2.2 |
| LACE-COMPUTER | Words-in-Noise Test (WIN) Change | 6 MONTH FOLLOW UP | 9.5 dB SNR | Standard Deviation 2.4 |
| LACE-COMPUTER | Words-in-Noise Test (WIN) Change | POST-INTERVENTION | 9.2 dB SNR | Standard Deviation 2.7 |
| LACE-COMPUTER | Words-in-Noise Test (WIN) Change | BASELINE | 9.9 dB SNR | Standard Deviation 2.7 |
| PLACEBO-DIRECTED LISTENING | Words-in-Noise Test (WIN) Change | BASELINE | 9.7 dB SNR | Standard Deviation 2.4 |
| PLACEBO-DIRECTED LISTENING | Words-in-Noise Test (WIN) Change | POST-INTERVENTION | 9 dB SNR | Standard Deviation 2 |
| PLACEBO-DIRECTED LISTENING | Words-in-Noise Test (WIN) Change | 6 MONTH FOLLOW UP | 9.4 dB SNR | Standard Deviation 2.3 |
| CONTROL | Words-in-Noise Test (WIN) Change | 6 MONTH FOLLOW UP | 9.8 dB SNR | Standard Deviation 2.2 |
| CONTROL | Words-in-Noise Test (WIN) Change | POST-INTERVENTION | 10 dB SNR | Standard Deviation 2.3 |
| CONTROL | Words-in-Noise Test (WIN) Change | BASELINE | 10.4 dB SNR | Standard Deviation 2.3 |
Secondary
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.
Time frame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Population: Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LACE-DVD | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | BASELINE | 32.3 units on a scale | Standard Deviation 17 |
| LACE-DVD | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | 6 MONTH FOLLOW UP | 30.45 units on a scale | Standard Deviation 18.1 |
| LACE-DVD | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | POST-INTERVENTION | 31 units on a scale | Standard Deviation 17 |
| LACE-COMPUTER | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | 6 MONTH FOLLOW UP | 33.65 units on a scale | Standard Deviation 17.75 |
| LACE-COMPUTER | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | BASELINE | 32 units on a scale | Standard Deviation 18 |
| LACE-COMPUTER | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | POST-INTERVENTION | 32 units on a scale | Standard Deviation 16.55 |
| PLACEBO-DIRECTED LISTENING | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | POST-INTERVENTION | 32 units on a scale | Standard Deviation 16 |
| PLACEBO-DIRECTED LISTENING | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | 6 MONTH FOLLOW UP | 33.15 units on a scale | Standard Deviation 18.7 |
| PLACEBO-DIRECTED LISTENING | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | BASELINE | 34 units on a scale | Standard Deviation 16 |
| CONTROL | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | 6 MONTH FOLLOW UP | 35.25 units on a scale | Standard Deviation 16.45 |
| CONTROL | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | BASELINE | 37 units on a scale | Standard Deviation 18.2 |
| CONTROL | Abbreviated Profile of Hearing Aid Benefit (APHAB) Change | POST-INTERVENTION | 33.6 units on a scale | Standard Deviation 16.1 |
Secondary
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.
Time frame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Population: Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LACE-DVD | Hearing Handicap Inventory for the Elderly (HHI) Change | POST-INTERVENTION | 25.65 units on a scale | Standard Deviation 19.65 |
| LACE-DVD | Hearing Handicap Inventory for the Elderly (HHI) Change | 6 MONTH FOLLOW UP | 24.1 units on a scale | Standard Deviation 19.7 |
| LACE-DVD | Hearing Handicap Inventory for the Elderly (HHI) Change | BASELINE | 29.4 units on a scale | Standard Deviation 22.6 |
| LACE-COMPUTER | Hearing Handicap Inventory for the Elderly (HHI) Change | BASELINE | 31.3 units on a scale | Standard Deviation 21.95 |
| LACE-COMPUTER | Hearing Handicap Inventory for the Elderly (HHI) Change | POST-INTERVENTION | 29.35 units on a scale | Standard Deviation 23.05 |
| LACE-COMPUTER | Hearing Handicap Inventory for the Elderly (HHI) Change | 6 MONTH FOLLOW UP | 27.85 units on a scale | Standard Deviation 21.05 |
| PLACEBO-DIRECTED LISTENING | Hearing Handicap Inventory for the Elderly (HHI) Change | 6 MONTH FOLLOW UP | 27.8 units on a scale | Standard Deviation 19.55 |
| PLACEBO-DIRECTED LISTENING | Hearing Handicap Inventory for the Elderly (HHI) Change | POST-INTERVENTION | 30.05 units on a scale | Standard Deviation 19.3 |
| PLACEBO-DIRECTED LISTENING | Hearing Handicap Inventory for the Elderly (HHI) Change | BASELINE | 29.95 units on a scale | Standard Deviation 20.15 |
| CONTROL | Hearing Handicap Inventory for the Elderly (HHI) Change | POST-INTERVENTION | 29.35 units on a scale | Standard Deviation 20.65 |
| CONTROL | Hearing Handicap Inventory for the Elderly (HHI) Change | 6 MONTH FOLLOW UP | 32.45 units on a scale | Standard Deviation 22 |
| CONTROL | Hearing Handicap Inventory for the Elderly (HHI) Change | BASELINE | 33.8 units on a scale | Standard Deviation 20.9 |