Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LACE-DVD | Experimental | Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode |
|
| LACE-COMPUTER | Experimental | Participants will complete a computer-based auditory training program (i.e., LACE) |
|
| PLACEBO-DIRECTED LISTENING | Active Comparator | Participants will complete a directed listening to books on CD treatment |
|
| CONTROL | Active Comparator | Participants will be provided with hearing aids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACE-computer | Behavioral | Computerized Auditory Training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
known neurological, psychiatric disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theresa Chisolm, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Bay Pines | Bay Pines | Florida | 33708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24018575 | Background | 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). | |
| 26901263 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LACE-DVD | DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training |
| FG001 | LACE - COMPUTER | Computer-based auditory training LACE: Computerized Auditory Training |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LACE-DVD | DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training |
| BG001 | LACE-COMPUTER | Computer-based auditory training LACE: Computerized Auditory Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | dB SNR | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LACE-DVD | DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel McArdle | Department of Veterans Affairs | 727-398-6661 | 17479 | Rachel.mcardle@va.gov |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PLACEBO-Directed listening |
| Behavioral |
Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along |
|
| CONTROL | Behavioral | No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids |
|
| Lace-DVD | Behavioral | DVD based Auditory Training |
|
| Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up |
| 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. | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | LACE-COMPUTER | Computer-based auditory training LACE: Computerized Auditory Training |
| OG002 | 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 |
| OG003 | 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 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | LACE-COMPUTER | Computer-based auditory training LACE: Computerized Auditory Training | 0 | 65 | 0 | 65 |
| EG002 | 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 | 0 | 73 | 0 | 73 |
| EG003 | 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 | 0 | 73 | 0 | 73 |
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| POST-INTERVENTION |
|
|
| 6 MONTH FOLLOW UP |
|
|
|
| POST-INTERVENTION |
|
|
| 6 MONTH FOLLOW UP |
|
|