Hearing LossLACENCT00727337
Supplementing Hearing Aids With Computerized Auditory Training
A study testing LACE-computer and Lace-DVD in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- LACE-computer and Lace-DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult onset hearing loss,
- English as the first language,
- bilateral, symmetric, sensorineural hearing loss,
- average audiometric thresholds for 500, 1000, and 2000 Hz less than 50-dB HL in either ear,
- aided speech recognition in quiet of 40% binaurally,
- appropriate cognitive skills assessed using the Mini Mental State Exam (Folstein et al., 1975) with age/education norms (Crum et al., 1993),
- adequate vision to participate in the study as determined with the Smith-Kettlewell Institute Low Luminance (SKILL) Card,
- eligible for VA-issued hearing aids.
Who cannot join
- known neurological, psychiatric disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708
About this study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- LACE-computer, PLACEBO-Directed listening, CONTROL, Lace-DVD
- Keywords
- auditory perception, rehabilitation of hearing impaired
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACE-computerBehavioural
Computerized Auditory Training
PLACEBO-Directed listeningBehavioural
Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along
CONTROLBehavioural
No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Lace-DVDBehavioural
DVD based Auditory Training
| Study group | Role | What they receive |
|---|---|---|
| LACE-DVD | Experimental | Participants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode Receives: Behavioral: Lace-DVD |
| LACE-COMPUTER | Experimental | Participants will complete a computer-based auditory training program (i.e., LACE) Receives: Behavioral: LACE-computer |
| PLACEBO-DIRECTED LISTENING | Active comparator | Participants will complete a directed listening to books on CD treatment Receives: Behavioral: PLACEBO-Directed listening |
| CONTROL | Active comparator | Participants will be provided with hearing aids Receives: Behavioral: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Theresa Chisolm, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727337
- Sponsor's protocol ID
- C6303-R
- Acronym
- LACE
- Status last verified
- Jun 2018
- First submitted
- 30 Jul 2008
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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).
PubMed 24018575Saunders 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.
PubMed 26901263
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementing Hearing Aids With Computerized Auditory Training
- ClinicalTrials.gov ID
- NCT00727337
- Acronym / sponsor ID
- LACE / C6303-R
- Conditions
- Hearing Loss
- Keywords
- auditory perception, rehabilitation of hearing impaired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Posted 13 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LACE-DVD | Experimental | Behavioral: Lace-DVDParticipants will complete the LACE training, however, not in an interactive computer mode but through a static DVD mode |
| LACE-COMPUTER | Experimental | Behavioral: LACE-computerParticipants will complete a computer-based auditory training program (i.e., LACE) |
| PLACEBO-DIRECTED LISTENING | Active comparator | Behavioral: PLACEBO-Directed listeningParticipants will complete a directed listening to books on CD treatment |
| CONTROL | Active comparator | Behavioral: CONTROLParticipants will be provided with hearing aids |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adult onset hearing loss,
- English as the first language,
- bilateral, symmetric, sensorineural hearing loss,
- average audiometric thresholds for 500, 1000, and 2000 Hz less than 50-dB HL in either ear,
- aided speech recognition in quiet of 40% binaurally,
Key exclusion criteria (1 listed)
- known neurological, psychiatric disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LACE-computerComputerized Auditory Training | Behavioural | LACE-COMPUTER |
| PLACEBO-Directed listeningSubjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along | Behavioural | PLACEBO-DIRECTED LISTENING |
| CONTROLNo specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids | Behavioural | CONTROL |
| Lace-DVDDVD based Auditory Training | Behavioural | LACE-DVD |
Primary outcome
Words-in-Noise Test (WIN) Change
Time frame: 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.
2 secondary outcomes
Abbreviated Profile of Hearing Aid Benefit (APHAB) Change
Time frame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Hearing Handicap Inventory for the Elderly (HHI) Change
Time frame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24018575Chisolm 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).
- Results publication: PubMed 26901263Saunders 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Chisolm, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LACE-computer and Lace-DVD in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Words-in-Noise Test (WIN) Change (time frame: Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.