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At-home Auditory Training Clinical Trial

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Indiana University

Status

Completed

Conditions

Aging
Hearing Loss
Presbycusis

Treatments

Behavioral: Auditory training program
Behavioral: Sham Comparator: Active Control

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01950013
1303010805
R01DC010135 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

55 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

45 participants in 3 patient groups

Passive Control
No Intervention group
Description:
Hearing aid alone
Training
Experimental group
Description:
Auditory Training Program. Hearing aid plus auditory training
Treatment:
Behavioral: Auditory training program
Active control
Sham Comparator group
Description:
Sham comparator: Active control. Hearing aid plus audio-book use
Treatment:
Behavioral: Sham Comparator: Active Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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