Aging, Hearing Loss, Presbycusis
Conditions
Keywords
Presbycusis, Aging, hearing aids, hearing training
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAuditory 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.
BEHAVIORALSham 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.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* •55-79 yrs of age * Native English speaker * Having corrected vision sufficient to read 18pt font on a computer screen * Wearing binaural hearing aids that were fitted within the past 3 years that are the only hearing aids the subject has ever worn
Exclusion criteria
* The hearing aids worn by the subject will be evaluated on the subject's ears and must be functioning as required for this study; otherwise, the subject will be excluded from participation until the hearing aids have been adjusted appropriately * asymmetrical hearing loss * presence of dementia, Parkinson's disease, or other neurological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Connected Speech Test (CST) Score | Baseline (prior to training) and 6-weeks later (after training) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aided Profile of Hearing Aid Performance (PHAP) Score | Baseline (pre-training) and 6 weeks later (post training) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No changes after enrollment except that 2 subjects withdrew prior to completion--see below.
Participants by arm
| Arm | Count |
|---|---|
| Passive Control Hearing aid alone | 15 |
| 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. | 13 |
| 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. | 15 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Passive Control | Total | Active Control | Training |
|---|---|---|---|---|
| Age, Continuous | 72.0 years STANDARD_DEVIATION 7.1 | 71.8 years STANDARD_DEVIATION 7 | 71.3 years STANDARD_DEVIATION 7.5 | 71.9 years STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 43 Participants | 15 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 43 Participants | 15 Participants | 13 Participants |
| Region of Enrollment United States | 15 participants | 43 participants | 15 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 31 Participants | 11 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 | 0 / 15 |
Outcome results
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.
Time frame: Baseline (prior to training) and 6-weeks later (after training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Control | Change in Connected Speech Test (CST) Score | 3.87 percent-correct words | Standard Deviation 11.37 |
| Training | Change in Connected Speech Test (CST) Score | -5.84 percent-correct words | Standard Deviation 22.54 |
| Active Control | Change in Connected Speech Test (CST) Score | -9.60 percent-correct words | Standard Deviation 16.9 |
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.
Time frame: Baseline (pre-training) and 6 weeks later (post training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Control | Change in Aided Profile of Hearing Aid Performance (PHAP) Score | -.03 proportion of time had difficulties | Standard Deviation 0.08 |
| Training | Change in Aided Profile of Hearing Aid Performance (PHAP) Score | .01 proportion of time had difficulties | Standard Deviation 0.09 |
| Active Control | Change in Aided Profile of Hearing Aid Performance (PHAP) Score | .00 proportion of time had difficulties | Standard Deviation 0.08 |