Clinical trial NCT01950013: At-home Auditory Training Clinical Trial
Official title: At-home Auditory Training Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbycusis
Aging
Hearing Loss
Keywords: Presbycusis
Aging
hearing aids
hearing training
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-09-25
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Connected Speech Test (CST) Score
timeFrame: Baseline (prior to training) and 6-weeks later (after training)
Secondary outcomes:
measure: Change in Aided Profile of Hearing Aid Performance (PHAP) Score
timeFrame: Baseline (pre-training) and 6 weeks later (post training)
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: IU Department of Speech & Hearing Sciences
state: Indiana
Study officials:
affiliation: Indiana University Department of Speech and Hearing Sciences
name: Larry E Humes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.