Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

At-home Auditory Training Clinical Trial (Training)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01950013
Recruitment Status : Completed
First Posted : September 25, 2013
Results First Posted : July 2, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Larry Humes, Indiana University

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.

Condition or disease Intervention/treatment Phase
Presbycusis Aging Hearing Loss Behavioral: Auditory training program Behavioral: Sham Comparator: Active Control Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: At-home Auditory Training Clinical Trial
Study Start Date : July 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
No Intervention: Passive Control
Hearing aid alone
Experimental: Training
Auditory Training Program. Hearing aid plus auditory training
Behavioral: 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.

Sham Comparator: Active control
Sham comparator: Active control. Hearing aid plus audio-book use
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Connected Speech Test (CST) Score [ Time Frame: 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 Outcome Measures :
  1. Change in Aided Profile of Hearing Aid Performance (PHAP) Score [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950013


Locations
Layout table for location information
United States, Indiana
IU Department of Speech & Hearing Sciences
Bloomington, Indiana, United States, 47405-7002
Sponsors and Collaborators
Indiana University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Layout table for investigator information
Principal Investigator: Larry E Humes, PhD Indiana University Department of Speech and Hearing Sciences

Layout table for additonal information
Responsible Party: Larry Humes, Distinguished Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01950013     History of Changes
Other Study ID Numbers: 1303010805
R01DC010135 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2013    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 16, 2019
Last Verified: July 2019

Keywords provided by Larry Humes, Indiana University:
Presbycusis
Aging
hearing aids
hearing training

Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural