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
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Presbycusis Aging Hearing Loss||Behavioral: Auditory training program Behavioral: Sham Comparator: Active Control||Not Applicable|
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). Each group will include 40 subjects. Those subjects in the training group and active control group will complete two five-week cycles of training and return to the lab for outcome measures after 10 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||At-home Auditory Training Clinical Trial|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
No Intervention: Passive Control
Hearing aid alone
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.
- Profile of Hearing Aid Performance (PHAP) [ Time Frame: One time: 10 weeks post session 1 ]The PHAP is a self-report survey about the benefits provided by the patient's hearing aids in a variety of listening situations.
- Connected Speech Test (CST) [ Time Frame: One time: 10 weeks post session 1 ]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.
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
|United States, Indiana|
|IU Department of Speech & Hearing Sciences|
|Bloomington, Indiana, United States, 47405-7002|
|Principal Investigator:||Larry E Humes, PhD||Indiana University Department of Speech and Hearing Sciences|