NCT02147847

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

May 15, 2014

Last Update Submit

October 17, 2016

Conditions

Presbycusis

Keywords

PresbycusisHearing In NoiseHearing ImpairmentHearing LossAgingPlasticityVideo GamesPerceptual Learning

Outcome Measures

Primary Outcomes (1)

  • Speech Perception in Noise

    Participants will report words spoken by a target speaker while several speakers serve as distractors.

    up to 3 months

Secondary Outcomes (3)

  • Frequency Modulation Detection

    up to 3 months

  • Stroop Task

    up to 3 months

  • Letter-Numbers Sequencing Test

    up to 3 months

Study Arms (2)

Video game based training 1

EXPERIMENTAL

Video Game play with training strategy 1

Behavioral: Video game based training 1

Video game based training 2

EXPERIMENTAL

Video Game play with training strategy 2

Behavioral: Video game based training 2

Interventions

Video game based training 1BEHAVIORAL

32 one-hour, home-based training sessions over 8 weeks

Video game based training 1
Video game based training 2BEHAVIORAL

32 one-hour, home-based training sessions over 8 weeks

Video game based training 2

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Binaural sensorineural hearing impairment
  • Use of binaural hearing aids
  • Native English Speaker

You may not qualify if:

  • Significant cognitive impairment
  • Significant motor impairment
  • History of neurological disease/head trauma
  • Use of psychotropic and thyroid medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Saint Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Hudson Valley Audiology Center

New City, New York, 10956, United States

Location

Related Publications (13)

  • 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.

    PMID: 23401541BACKGROUND

  • 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.

    PMID: 17896103BACKGROUND

  • 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.

    PMID: 15534214BACKGROUND

  • 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.

    PMID: 16672673BACKGROUND

  • 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.

    PMID: 21912514BACKGROUND

  • 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.

    PMID: 16999250BACKGROUND

  • 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.

    PMID: 15286790BACKGROUND

  • Green CS, Bavelier D. Action video game modifies visual selective attention. Nature. 2003 May 29;423(6939):534-7. doi: 10.1038/nature01647.

    PMID: 12774121BACKGROUND

  • 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.

    PMID: 20833324BACKGROUND

  • 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.

    PMID: 24556432BACKGROUND

  • 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.

    PMID: 23618662BACKGROUND

  • 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.

    PMID: 21827533BACKGROUND

  • 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.

    PMID: 8539603BACKGROUND

Related Links

MeSH Terms

Conditions

PresbycusisHearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Polley, Ph.D.

    Massachusetts Eye and Ear Infirmary, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Department of Otology and Laryngology

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 28, 2014

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-05

Locations

US(3)