LACE: Supplementing Hearing Aids With Computerized Auditory Training

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00727337
• Collaborator: (none)
• Enrollment: 279
• Location: 1
• Arms: 4
• Duration (Months): 35
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Behavioral: LACE-computer; Behavioral: PLACEBO-Directed listening; Behavioral: CONTROL; Behavioral: Lace-DVD	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 279 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Supplementing Hearing Aids With Computerized Auditory Training
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LACE-DVD Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode	Behavioral: Lace-DVD; DVD based Auditory Training
Experimental: LACE-COMPUTER Participants will complete a computer-based auditory training program (i.e., LACE)	Behavioral: LACE-computer; Computerized Auditory Training
Active Comparator: PLACEBO-DIRECTED LISTENING Participants will complete a directed listening to books on CD treatment	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
Active Comparator: CONTROL Participants will be provided with hearing aids	Behavioral: CONTROL; No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Bay Pines	Bay Pines	Florida	United States	33708

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Theresa Chisolm, PhD, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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).

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00727337
• Other Study ID Numbers: C6303-R
• First Posted: Aug 4, 2008
• Last Update Posted: Jul 18, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by VA Office of Research and Development: auditory perception; rehabilitation of hearing impaired
• Additional relevant MeSH terms: Hearing Loss

Study Results

Participant Flow

Arm/Group Title	LACE-DVD	LACE - COMPUTER	PLACEBO-DIRECTED LISTENING	CONTROL
Arm/Group Description	DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training	Computer-based auditory training LACE: Computerized Auditory Training	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	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
Period Title: Overall Study
STARTED	68	65	73	73
COMPLETED	61	55	63	64
NOT COMPLETED	7	10	10	9

Baseline Characteristics

Arm/Group Title	LACE-DVD	LACE-COMPUTER	PLACEBO-DIRECTED LISTENING	CONTROL	Total
Arm/Group Description	DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training	Computer-based auditory training LACE: Computerized Auditory Training	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	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 of all reporting groups
Overall Participants	68	65	73	73	279
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	28 41.2%	23 35.4%	37 50.7%	21 28.8%	109 39.1%
>=65 years	40 58.8%	42 64.6%	36 49.3%	52 71.2%	170 60.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.2 (7.7)	69 (7.8)	67.1 (7.7)	70 (7.3)	68.6 (7.7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	68 100%	65 100%	73 100%	73 100%	279 100%
Region of Enrollment (Count of Participants)
United States	68 100%	65 100%	73 100%	73 100%	279 100%

Outcome Measures

1. Primary Outcome

Title	Words-in-Noise Test (WIN) Change
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	LACE-DVD	LACE-COMPUTER	PLACEBO-DIRECTED LISTENING	CONTROL
Arm/Group Description	DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training	Computer-based auditory training LACE: Computerized Auditory Training	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	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
Measure Participants	68	65	73	73
BASELINE	9.8 (2.2)	9.9 (2.7)	9.7 (2.4)	10.4 (2.3)
POST-INTERVENTION	9 (2.3)	9.2 (2.7)	9 (2)	10 (2.3)
6 MONTH FOLLOW UP	9.3 (2.2)	9.5 (2.4)	9.4 (2.3)	9.8 (2.2)

2. Secondary Outcome

Title	Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	LACE-DVD	LACE-COMPUTER	PLACEBO-DIRECTED LISTENING	CONTROL
Arm/Group Description	Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode Lace-DVD: DVD based Auditory Training	Participants will complete a computer-based auditory training program (i.e., LACE) LACE-computer: Computerized Auditory Training	Participants will complete a directed listening to books on CD treatment 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	Participants will be provided with hearing aids CONTROL: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Measure Participants	68	65	73	73
BASELINE	32.3 (17)	32 (18)	34 (16)	37 (18.2)
POST-INTERVENTION	31 (17)	32 (16.55)	32 (16)	33.6 (16.1)
6 MONTH FOLLOW UP	30.45 (18.1)	33.65 (17.75)	33.15 (18.7)	35.25 (16.45)

3. Secondary Outcome

Title	Hearing Handicap Inventory for the Elderly (HHI) Change
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	LACE-DVD	LACE - COMPUTER	PLACEBO-DIRECTED LISTENING	CONTROL
Arm/Group Description	DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training	Computer-based auditory training LACE: Computerized Auditory Training	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	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
Measure Participants	68	65	73	73
BASELINE	29.4 (22.6)	31.3 (21.95)	29.95 (20.15)	33.8 (20.9)
POST-INTERVENTION	25.65 (19.65)	29.35 (23.05)	30.05 (19.3)	29.35 (20.65)
6 MONTH FOLLOW UP	24.1 (19.7)	27.85 (21.05)	27.8 (19.55)	32.45 (22)

Adverse Events

Arm/Group Title	LACE-DVD		LACE-COMPUTER		PLACEBO-DIRECTED LISTENING		CONTROL
Arm/Group Description	DVD-based auditory training Auditory Training with DVD: DVD based Auditory Training		Computer-based auditory training LACE: Computerized Auditory Training		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		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
All Cause Mortality
	LACE-DVD		LACE-COMPUTER		PLACEBO-DIRECTED LISTENING		CONTROL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	LACE-DVD		LACE-COMPUTER		PLACEBO-DIRECTED LISTENING		CONTROL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/65 (0%)		0/73 (0%)		0/73 (0%)
Other (Not Including Serious) Adverse Events
	LACE-DVD		LACE-COMPUTER		PLACEBO-DIRECTED LISTENING		CONTROL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/65 (0%)		0/73 (0%)		0/73 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.