At-home Auditory Training Clinical Trial (Training)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Larry Humes, Indiana University
ClinicalTrials.gov Identifier:
NCT01950013
First received: August 2, 2013
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Presbycusis
Aging
Hearing Loss
Behavioral: Auditory training program
Behavioral: Sham Comparator: Active Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: At-home Auditory Training Clinical Trial

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Profile of Hearing Aid Performance (PHAP) [ Time Frame: One time: 10 weeks post session 1 ] [ Designated as safety issue: No ]
    The PHAP is a self-report survey about the benefits provided by the patient's hearing aids in a variety of listening situations.


Secondary Outcome Measures:
  • Connected Speech Test (CST) [ Time Frame: One time: 10 weeks post session 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: July 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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). 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.

  Eligibility

Ages Eligible for Study:   55 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950013

Locations
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
Principal Investigator: Larry E Humes, PhD Indiana University Department of Speech and Hearing Sciences
  More Information

Responsible Party: Larry Humes, Distinguished Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01950013     History of Changes
Other Study ID Numbers: 1303010805  R01DC010135 
Study First Received: August 2, 2013
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Indiana University:
Presbycusis
Aging
hearing aids
hearing training

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

ClinicalTrials.gov processed this record on July 25, 2016