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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Video game based training 1 | Experimental | Video Game play with training strategy 1 Receives: Behavioral: Video game based training 1 |
| Video game based training 2 | Experimental | Video 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.
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)
Frequency Modulation Detection
We will measure the detectability of frequency excursions psychoacoustically.
Measured: up to 3 months
Stroop Task
Participants will be asked to attend and report one feature of a stimulus while ignoring another
Measured: up to 3 months
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.
- First posted28 May 2014 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PresbycusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Polley, Massachusetts Eye and Ear Infirmary
- Investigators
- Daniel Polley, Ph.D., Principal investigator, Massachusetts Eye and Ear Infirmary, Harvard Medical School
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 23401541Keeling 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 17896103Polley 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 15534214Polley 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 16672673Li 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 21912514Sweetow 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 16999250Bao 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 15286790Green CS, Bavelier D. Action video game modifies visual selective attention. Nature. 2003 May 29;423(6939):534-7. doi: 10.1038/nature01647.
PubMed 12774121Green 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 20833324Deveau 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 24556432Li 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 23618662Lim 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 21827533Merzenich 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Treatment to Improve the Hearing in Noise Abilities of Older Adults With Hearing Impairments.
- ClinicalTrials.gov ID
- NCT02147847
- Acronym / sponsor ID
- 11-006H-AUD
- Conditions
- Presbycusis
- Keywords
- Presbycusis, Hearing In Noise, Hearing Impairment, Hearing Loss, Aging, Plasticity, Video Games, Perceptual Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video game based training 1 | Experimental | Behavioral: Video game based training 1Video Game play with training strategy 1 |
| Video game based training 2 | Experimental | Behavioral: Video game based training 2Video Game play with training strategy 2 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Binaural sensorineural hearing impairment
- Use of binaural hearing aids
- Native English Speaker
Key exclusion criteria (4 listed)
- Significant cognitive impairment
- Significant motor impairment
- History of neurological disease/head trauma
- Use of psychotropic and thyroid medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video game based training 132 one-hour, home-based training sessions over 8 weeks | Behavioural | Video game based training 1 |
| Video game based training 232 one-hour, home-based training sessions over 8 weeks | Behavioural | Video game based training 2 |
Primary outcome
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.
3 secondary outcomes
Frequency Modulation Detection
Time frame: up to 3 months
Stroop Task
Time frame: up to 3 months
Letter-Numbers Sequencing Test
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 23401541Anderson 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.
- Background: PubMed 17896103Keeling 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.
- Background: PubMed 15534214Polley 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.
- Background: PubMed 16672673Polley 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.
- Background: PubMed 21912514Li 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.
- Background: PubMed 16999250Sweetow 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.
- Background: PubMed 15286790Bao 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.
- Background: PubMed 12774121Green CS, Bavelier D. Action video game modifies visual selective attention. Nature. 2003 May 29;423(6939):534-7. doi: 10.1038/nature01647.
- Background: PubMed 20833324Green 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.
- Background: PubMed 24556432Deveau 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.
- Background: PubMed 23618662Li 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.
- Background: PubMed 21827533Lim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Polley, Ph.D. principal investigator
Massachusetts Eye and Ear Infirmary, Harvard Medical School
3 sites in 1 country: see every site and its status.
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.