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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC010135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The purpose of this study is to investigate the effectiveness of an auditory training program used at home with the subject's own hearing aids.
The most common communication complaint of older adults with impaired hearing is that they can hear speech, but can't understand it. This is especially true where there are competing sounds in the background. Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. All testing for the screening, baseline speech testing, training system orientation, and the outcomes portions of this project will be conducted in the Audiology Research Laboratory (ARL) of the Speech and Hearing Center located at 200 South Jordan Avenue. The use of the training program will be done at the subject's home.
Subjects will first come to the ARL for either one session for a hearing aid follow-up and instruction in the use of the training system (Session 1) or for one session for an initial screening to determine eligibility (Screening) followed then by Session 1. Subjects will then take home a training system that includes a tablet computer that has the training program loaded onto it, a portable loudspeaker, and some accessories. There will be three groups of subjects: (1) Hearing aid alone--no training (passive control); (2) Hearing aid plus auditory training (training); and (3) Hearing aid plus audio book use (active control). Total enrollment will be 45 subjects. Those subjects in the training group and active control group will complete a 6-week training period and return to the lab for outcome measures after 6 weeks of training for the primary and secondary outcome measures. The hearing aid alone group will return for the same outcome measures as the training and active control groups, but will have no intervention between these follow-up sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive Control | No Intervention | Hearing aid alone | |
| Training | Experimental | Auditory Training Program. Hearing aid plus auditory training |
|
| Active control | Sham Comparator | Sham comparator: Active control. Hearing aid plus audio-book use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory training program | Behavioral | Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Connected Speech Test (CST) Score | The CST is an "objective" measure of speech-understanding in noise that will be obtained when the patient's are wearing their hearing aids. The patient hears standardized recordings of the speech in noise and then reports the sentences that were heard. These are scored as percent correct. Baseline AIDED CST score was obtained prior to the intervention period and immediately following 6-week intervention. The results reflect the CHANGE in CST from pre- to post-intervention with positive numbers indicating improved speech understanding in noise following training. | Baseline (prior to training) and 6-weeks later (after training) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aided Profile of Hearing Aid Performance (PHAP) Score | Change in aided performance on the Profile of Hearing Aid Performance (PHAP), a self-report measure of the frequency of listening difficulties experienced by the individual. The aided PHAP scores are proportions of time difficulties encountered in various listening situations while wearing hearing aids. Low PHAP scores indicate less frequent difficulties and reflect better aided performance. The range of possible PHAP scores are 0.0 to 1.0.There are seven subscales of the PHAP and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHAP global. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). Scores reported below are the CHANGE in aided PHAP global scores, baseline minus post-training. |
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Inclusion Criteria:
•55-79 yrs of age
Native English speaker
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry E Humes, PhD | Indiana University Department of Speech and Hearing Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Department of Speech & Hearing Sciences | Bloomington | Indiana | 47405-7002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30575602 | Derived | Humes LE, Skinner KG, Kinney DL, Rogers SE, Main AK, Quigley TM. Clinical Effectiveness of an At-Home Auditory Training Program: A Randomized Controlled Trial. Ear Hear. 2019 Sep/Oct;40(5):1043-1060. doi: 10.1097/AUD.0000000000000688. |
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No changes after enrollment except that 2 subjects withdrew prior to completion--see below.
Recruiting for this study began May 1, 2013 and the final follow-up session took place on February 5, 2015. Forty-five people were recruited from a previous clinical trial on hearing aids in the lab or through newspaper advertisements and flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Passive Control | Hearing aid alone |
| FG001 | Training | Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. |
| FG002 | Active Control | Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Passive Control | Hearing aid alone |
| BG001 | Training | Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Connected Speech Test (CST) Score | The CST is an "objective" measure of speech-understanding in noise that will be obtained when the patient's are wearing their hearing aids. The patient hears standardized recordings of the speech in noise and then reports the sentences that were heard. These are scored as percent correct. Baseline AIDED CST score was obtained prior to the intervention period and immediately following 6-week intervention. The results reflect the CHANGE in CST from pre- to post-intervention with positive numbers indicating improved speech understanding in noise following training. | Posted | Mean | Standard Deviation | percent-correct words | Baseline (prior to training) and 6-weeks later (after training) |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Passive Control | Hearing aid alone | 0 |
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The findings are limited to the efficacy and effectiveness of a relatively brief (6-week, 3x/week) at-home training regimen for older adults wearing hearing aids. More training could lead to improved benefits in everyday listening.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Humes | Indiana University, Dept of Speech & Hearing Sci | 812-855-3507 | humes@indiana.edu |
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| ID | Term |
|---|---|
| D011304 | Presbycusis |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| Sham Comparator: Active Control | Behavioral | This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training. |
|
| Baseline (pre-training) and 6 weeks later (post training) |
| BG002 | Active Control | Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Midwestern United States-southcentral Indiana. | Number | participants |
|
Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. |
| OG002 | Active Control | Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training. |
|
|
| Secondary | Change in Aided Profile of Hearing Aid Performance (PHAP) Score | Change in aided performance on the Profile of Hearing Aid Performance (PHAP), a self-report measure of the frequency of listening difficulties experienced by the individual. The aided PHAP scores are proportions of time difficulties encountered in various listening situations while wearing hearing aids. Low PHAP scores indicate less frequent difficulties and reflect better aided performance. The range of possible PHAP scores are 0.0 to 1.0.There are seven subscales of the PHAP and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHAP global. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). Scores reported below are the CHANGE in aided PHAP global scores, baseline minus post-training. | Posted | Mean | Standard Deviation | proportion of time had difficulties | Baseline (pre-training) and 6 weeks later (post training) |
|
|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Training | Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Active Control | Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |