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PresbycusisNCT02147847

Computer-Based Auditory Rehabilitation

A study testing Video game based training 1 and Video game based training 2 in people with Presbycusis, run by Massachusetts Eye and Ear Infirmary at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Presbycusis
What is being tested?
Video game based training 1 and Video game based training 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesUnited States
Study dates
Apr 2015to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Saint Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Hudson Valley Audiology Center

    New City, New York, 10956

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Presbycusis
Being tested
Video game based training 1, Video game based training 2
Keywords
Presbycusis, Hearing In Noise, Hearing Impairment, Hearing Loss, Aging, Plasticity, Video Games, Perceptual Learning
Medical subject headings
Presbycusis, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video game based training 1Behavioural

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

  • Video game based training 2Behavioural

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

Study groups in NCT02147847
Study groupRoleWhat they receive
Video game based training 1ExperimentalVideo Game play with training strategy 1
Receives: Behavioral: Video game based training 1
Video game based training 2ExperimentalVideo Game play with training strategy 2
Receives: Behavioral: Video game based training 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech Perception in Noise

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

    Measured: up to 3 months

Secondary outcomes (3)

  1. Frequency Modulation Detection

    We will measure the detectability of frequency excursions psychoacoustically.

    Measured: up to 3 months

  2. Stroop Task

    Participants will be asked to attend and report one feature of a stimulus while ignoring another

    Measured: up to 3 months

  3. Letter-Numbers Sequencing Test

    Participants are asked to repeat a string of letters and numbers.

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02147847
Sponsor's protocol ID
11-006H-AUD
Status last verified
May 2016
First submitted
15 May 2014
Last updated
18 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23401541

  • 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.

    PubMed 17896103

  • 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.

    PubMed 15534214

  • 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.

    PubMed 16672673

  • 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.

    PubMed 21912514

  • 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.

    PubMed 16999250

  • 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.

    PubMed 15286790

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

    PubMed 12774121

  • 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.

    PubMed 20833324

  • 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.

    PubMed 24556432

  • 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.

    PubMed 23618662

  • 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.

    PubMed 21827533

  • 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.

    PubMed 8539603

Questions about this trial

What is this clinical trial studying?

A study testing Video game based training 1 and Video game based training 2 in people with Presbycusis, run by Massachusetts Eye and Ear Infirmary at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech Perception in Noise (time frame: up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02147847, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.

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