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At-home Auditory Training Clinical Trial (Training)

Primary Purpose

Presbycusis, Aging, Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory training program
Sham Comparator: Active Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbycusis focused on measuring Presbycusis, Aging, hearing aids, hearing training

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IU Department of Speech & Hearing Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Sham Comparator

Arm Label

Passive Control

Training

Active control

Arm Description

Hearing aid alone

Auditory Training Program. Hearing aid plus auditory training

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

Outcomes

Primary Outcome Measures

Change in Connected Speech Test (CST) Score
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

Change in Aided Profile of Hearing Aid Performance (PHAP) Score
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.

Full Information

First Posted
August 2, 2013
Last Updated
July 3, 2019
Sponsor
Indiana University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT01950013
Brief Title
At-home Auditory Training Clinical Trial
Acronym
Training
Official Title
At-home Auditory Training Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbycusis, Aging, Hearing Loss
Keywords
Presbycusis, Aging, hearing aids, hearing training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Control
Arm Type
No Intervention
Arm Description
Hearing aid alone
Arm Title
Training
Arm Type
Experimental
Arm Description
Auditory Training Program. Hearing aid plus auditory training
Arm Title
Active control
Arm Type
Sham Comparator
Arm Description
Sham comparator: Active control. Hearing aid plus audio-book use
Intervention Type
Behavioral
Intervention Name(s)
Auditory training program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham Comparator: Active Control
Intervention Description
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 Measure Information:
Title
Change in Connected Speech Test (CST) Score
Description
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.
Time Frame
Baseline (prior to training) and 6-weeks later (after training)
Secondary Outcome Measure Information:
Title
Change in Aided Profile of Hearing Aid Performance (PHAP) Score
Description
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.
Time Frame
Baseline (pre-training) and 6 weeks later (post training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry E Humes, PhD
Organizational Affiliation
Indiana University Department of Speech and Hearing Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Department of Speech & Hearing Sciences
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405-7002
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30575602
Citation
Humes LE, Skinner KG, Kinney DL, Rogers SE, Main AK, Quigley TM. Clinical Effectiveness of an At-Home Auditory Training Program: A Randomized Controlled Trial. Ear Hear. 2019 Sep/Oct;40(5):1043-1060. doi: 10.1097/AUD.0000000000000688.
Results Reference
derived

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At-home Auditory Training Clinical Trial

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