Trial Outcomes & Findings for Supplementing Hearing Aids With Computerized Auditory Training (NCT NCT00727337)
NCT ID: NCT00727337
Last Updated: 2018-07-18
Results Overview
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.
COMPLETED
NA
279 participants
Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
2018-07-18
Participant Flow
Participant milestones
| Measure |
LACE-DVD
DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training
|
LACE - COMPUTER
Computer-based auditory training
LACE: Computerized Auditory Training
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
68
|
65
|
73
|
73
|
|
Overall Study
COMPLETED
|
61
|
55
|
63
|
64
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supplementing Hearing Aids With Computerized Auditory Training
Baseline characteristics by cohort
| Measure |
LACE-DVD
n=68 Participants
DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training
|
LACE-COMPUTER
n=65 Participants
Computer-based auditory training
LACE: Computerized Auditory Training
|
PLACEBO-DIRECTED LISTENING
n=73 Participants
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
|
CONTROL
n=73 Participants
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
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
69 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
70 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
68.6 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
279 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
279 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
LACE-DVD
n=68 Participants
DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training
|
LACE-COMPUTER
n=65 Participants
Computer-based auditory training
LACE: Computerized Auditory Training
|
PLACEBO-DIRECTED LISTENING
n=73 Participants
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
|
CONTROL
n=73 Participants
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
|
|---|---|---|---|---|
|
Words-in-Noise Test (WIN) Change
POST-INTERVENTION
|
9 dB SNR
Standard Deviation 2.3
|
9.2 dB SNR
Standard Deviation 2.7
|
9 dB SNR
Standard Deviation 2
|
10 dB SNR
Standard Deviation 2.3
|
|
Words-in-Noise Test (WIN) Change
BASELINE
|
9.8 dB SNR
Standard Deviation 2.2
|
9.9 dB SNR
Standard Deviation 2.7
|
9.7 dB SNR
Standard Deviation 2.4
|
10.4 dB SNR
Standard Deviation 2.3
|
|
Words-in-Noise Test (WIN) Change
6 MONTH FOLLOW UP
|
9.3 dB SNR
Standard Deviation 2.2
|
9.5 dB SNR
Standard Deviation 2.4
|
9.4 dB SNR
Standard Deviation 2.3
|
9.8 dB SNR
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
LACE-DVD
n=68 Participants
DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training
|
LACE-COMPUTER
n=65 Participants
Computer-based auditory training
LACE: Computerized Auditory Training
|
PLACEBO-DIRECTED LISTENING
n=73 Participants
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
|
CONTROL
n=73 Participants
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
|
|---|---|---|---|---|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
BASELINE
|
32.3 units on a scale
Standard Deviation 17
|
32 units on a scale
Standard Deviation 18
|
34 units on a scale
Standard Deviation 16
|
37 units on a scale
Standard Deviation 18.2
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
POST-INTERVENTION
|
31 units on a scale
Standard Deviation 17
|
32 units on a scale
Standard Deviation 16.55
|
32 units on a scale
Standard Deviation 16
|
33.6 units on a scale
Standard Deviation 16.1
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
6 MONTH FOLLOW UP
|
30.45 units on a scale
Standard Deviation 18.1
|
33.65 units on a scale
Standard Deviation 17.75
|
33.15 units on a scale
Standard Deviation 18.7
|
35.25 units on a scale
Standard Deviation 16.45
|
SECONDARY outcome
Timeframe: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
LACE-DVD
n=68 Participants
DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training
|
LACE-COMPUTER
n=65 Participants
Computer-based auditory training
LACE: Computerized Auditory Training
|
PLACEBO-DIRECTED LISTENING
n=73 Participants
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
|
CONTROL
n=73 Participants
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
|
|---|---|---|---|---|
|
Hearing Handicap Inventory for the Elderly (HHI) Change
BASELINE
|
29.4 units on a scale
Standard Deviation 22.6
|
31.3 units on a scale
Standard Deviation 21.95
|
29.95 units on a scale
Standard Deviation 20.15
|
33.8 units on a scale
Standard Deviation 20.9
|
|
Hearing Handicap Inventory for the Elderly (HHI) Change
POST-INTERVENTION
|
25.65 units on a scale
Standard Deviation 19.65
|
29.35 units on a scale
Standard Deviation 23.05
|
30.05 units on a scale
Standard Deviation 19.3
|
29.35 units on a scale
Standard Deviation 20.65
|
|
Hearing Handicap Inventory for the Elderly (HHI) Change
6 MONTH FOLLOW UP
|
24.1 units on a scale
Standard Deviation 19.7
|
27.85 units on a scale
Standard Deviation 21.05
|
27.8 units on a scale
Standard Deviation 19.55
|
32.45 units on a scale
Standard Deviation 22
|
Adverse Events
LACE-DVD
LACE-COMPUTER
PLACEBO-DIRECTED LISTENING
CONTROL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place