At-home Auditory Training Clinical Trial

NCT ID: NCT01950013

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-02-28

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.

Conditions

Presbycusis; Aging; Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Passive Control

Hearing aid alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Training

Auditory Training Program. Hearing aid plus auditory training

Group Type: EXPERIMENTAL

Auditory training program

Intervention Type: BEHAVIORAL

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.

Active control

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

Group Type: SHAM_COMPARATOR

Sham Comparator: Active Control

Intervention Type: BEHAVIORAL

This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Larry Humes

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry E Humes, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Department of Speech and Hearing Sciences

Locations

IU Department of Speech & Hearing Sciences

Bloomington, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30575602 (View on PubMed)

Other Identifiers

R01DC010135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1303010805

Identifier Type: -

Identifier Source: org_study_id