At-home Auditory Training Clinical Trial
Training
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
September 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
July 2, 2019
CompletedJuly 16, 2019
July 1, 2019
1.6 years
August 2, 2013
May 23, 2019
July 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (prior to training) and 6-weeks later (after training)
Secondary Outcomes (1)
Change in Aided Profile of Hearing Aid Performance (PHAP) Score
Baseline (pre-training) and 6 weeks later (post training)
Study Arms (3)
Passive Control
NO INTERVENTIONHearing aid alone
Training
EXPERIMENTALAuditory Training Program. Hearing aid plus auditory training
Active control
SHAM COMPARATORSham comparator: Active control. Hearing aid plus audio-book use
Interventions
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.
This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IU Department of Speech & Hearing Sciences
Bloomington, Indiana, 47405-7002, United States
Related Publications (1)
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.
PMID: 30575602DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The findings are limited to the efficacy and effectiveness of a relatively brief (6-week, 3x/week) at-home training regimen for older adults wearing hearing aids. More training could lead to improved benefits in everyday listening.
Results Point of Contact
- Title
- Larry Humes
- Organization
- Indiana University, Dept of Speech & Hearing Sci
Study Officials
- PRINCIPAL INVESTIGATOR
Larry E Humes, PhD
Indiana University Department of Speech and Hearing Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
August 2, 2013
First Posted
September 25, 2013
Study Start
July 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
July 16, 2019
Results First Posted
July 2, 2019
Record last verified: 2019-07