- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02147847
Computer-Based Auditory Rehabilitation
October 17, 2016 updated by: Daniel Polley, Massachusetts Eye and Ear Infirmary
Neurological Treatment to Improve the Hearing in Noise Abilities of Older Adults With Hearing Impairments.
Hearing in noisy environments is a perceptual problem that is ubiquitous in modern industrialized societies.
This particular listening context offers a particular challenge to individuals living with hearing impairment (30 million in US alone) even after treatment with hearing aids or cochlear implants.
The ability of the brain to extract regularities from the environment and suppress distracting information can be improved with intensive cognitive training.
The investigators will test whether the hearing in noise abilities of adults living with hearing impairment can be improved with a cognitive training paradigm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hearing impairment (HI) represents the most common cause of moderate to severe disability in the world, with an estimated prevalence of 636 million individuals (30 million in the US alone).
Amplification devices (i.e., hearing aids) are commonly used to compensate for HI stemming from acoustic trauma, ototoxic insult, normal aging or other sources of cochlear degeneration.
The chief complaint of individuals with HI is hearing in the types of noisy environments that characterize most work, educational, and social situations.
Unfortunately, hearing aids do not completely address the perceptual impairments in these situations.
That is because the difficulties that individuals with HI have hearing in noise result from the reduced salience of cues that are used to sort out auditory scenes.
Making sounds louder improves audibility, but does not afford adaptation of the brain to the abnormal coding of sensory information by the damaged cochlea.
The investigators will test whether the hearing in noise abilities of adults living with hearing impairment can be improved with a cognitive training paradigm.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
-
Brighton, Massachusetts, United States, 02135
- Saint Elizabeth's Medical Center
-
-
New York
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New City, New York, United States, 10956
- Hudson Valley Audiology Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Binaural sensorineural hearing impairment
- Use of binaural hearing aids
- Native English Speaker
Exclusion Criteria:
- Significant cognitive impairment
- Significant motor impairment
- History of neurological disease/head trauma
- Use of psychotropic and thyroid medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video game based training 1
Video Game play with training strategy 1
|
32 one-hour, home-based training sessions over 8 weeks
|
|
Experimental: Video game based training 2
Video Game play with training strategy 2
|
32 one-hour, home-based training sessions over 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech Perception in Noise
Time Frame: up to 3 months
|
Participants will report words spoken by a target speaker while several speakers serve as distractors.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency Modulation Detection
Time Frame: up to 3 months
|
We will measure the detectability of frequency excursions psychoacoustically.
|
up to 3 months
|
|
Stroop Task
Time Frame: up to 3 months
|
Participants will be asked to attend and report one feature of a stimulus while ignoring another
|
up to 3 months
|
|
Letter-Numbers Sequencing Test
Time Frame: up to 3 months
|
Participants are asked to repeat a string of letters and numbers.
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Polley, Ph.D., Massachusetts Eye and Ear Infirmary, Harvard Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Green CS, Bavelier D. Action video game modifies visual selective attention. Nature. 2003 May 29;423(6939):534-7. doi: 10.1038/nature01647.
- Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30.
- Anderson S, White-Schwoch T, Parbery-Clark A, Kraus N. Reversal of age-related neural timing delays with training. Proc Natl Acad Sci U S A. 2013 Mar 12;110(11):4357-62. doi: 10.1073/pnas.1213555110. Epub 2013 Feb 11.
- Keeling MD, Calhoun BM, Kruger K, Polley DB, Schreiner CE. Spectral integration plasticity in cat auditory cortex induced by perceptual training. Exp Brain Res. 2008 Feb;184(4):493-509. doi: 10.1007/s00221-007-1115-9. Epub 2007 Sep 21.
- Polley DB, Heiser MA, Blake DT, Schreiner CE, Merzenich MM. Associative learning shapes the neural code for stimulus magnitude in primary auditory cortex. Proc Natl Acad Sci U S A. 2004 Nov 16;101(46):16351-6. doi: 10.1073/pnas.0407586101. Epub 2004 Nov 8.
- Polley DB, Steinberg EE, Merzenich MM. Perceptual learning directs auditory cortical map reorganization through top-down influences. J Neurosci. 2006 May 3;26(18):4970-82. doi: 10.1523/JNEUROSCI.3771-05.2006.
- Sweetow RW, Sabes JH. The need for and development of an adaptive Listening and Communication Enhancement (LACE) Program. J Am Acad Audiol. 2006 Sep;17(8):538-58. doi: 10.3766/jaaa.17.8.2.
- Bao S, Chang EF, Woods J, Merzenich MM. Temporal plasticity in the primary auditory cortex induced by operant perceptual learning. Nat Neurosci. 2004 Sep;7(9):974-81. doi: 10.1038/nn1293. Epub 2004 Aug 1.
- Green CS, Pouget A, Bavelier D. Improved probabilistic inference as a general learning mechanism with action video games. Curr Biol. 2010 Sep 14;20(17):1573-9. doi: 10.1016/j.cub.2010.07.040.
- Deveau J, Ozer DJ, Seitz AR. Improved vision and on-field performance in baseball through perceptual learning. Curr Biol. 2014 Feb 17;24(4):R146-7. doi: 10.1016/j.cub.2014.01.004. No abstract available.
- Li J, Thompson B, Deng D, Chan LY, Yu M, Hess RF. Dichoptic training enables the adult amblyopic brain to learn. Curr Biol. 2013 Apr 22;23(8):R308-9. doi: 10.1016/j.cub.2013.01.059.
- Lim SJ, Holt LL. Learning foreign sounds in an alien world: videogame training improves non-native speech categorization. Cogn Sci. 2011 Sep-Oct;35(7):1390-405. doi: 10.1111/j.1551-6709.2011.01192.x. Epub 2011 Aug 9.
- Merzenich MM, Jenkins WM, Johnston P, Schreiner C, Miller SL, Tallal P. Temporal processing deficits of language-learning impaired children ameliorated by training. Science. 1996 Jan 5;271(5245):77-81. doi: 10.1126/science.271.5245.77.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
May 15, 2014
First Submitted That Met QC Criteria
May 27, 2014
First Posted (Estimate)
May 28, 2014
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-006H-AUD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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