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Clinical Trials/NCT01950013
NCT01950013CompletedNot Applicable

At-home Auditory Training Clinical Trial

Indiana University1 site in 1 country45 target enrollmentStarted: July 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Change in Connected Speech Test (CST) Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Passive Control

No Intervention

Hearing aid alone

Training

Experimental

Auditory Training Program. Hearing aid plus auditory training

Intervention: Auditory training program (Behavioral)

Active control

Sham Comparator

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

Intervention: Sham Comparator: Active Control (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Aided Profile of Hearing Aid Performance (PHAP) Score(Baseline (pre-training) and 6 weeks later (post training))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Larry Humes

Distinguished Professor

Indiana University

Study Sites (1)

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