Computer-Based Auditory Rehabilitation

Presbycusis Clinical Trial

Official title:

Neurological Treatment to Improve the Hearing in Noise Abilities of Older Adults With Hearing Impairments.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147847
• Other study ID #: 11-006H-AUD
• Status: Completed
• Phase: N/A
• First received: May 15, 2014
• Last updated: October 17, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss
• Presbycusis

Intervention

Behavioral:
• Video game based training 1
32 one-hour, home-based training sessions over 8 weeks
• Video game based training 2
32 one-hour, home-based training sessions over 8 weeks

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Saint Elizabeth's Medical Center	Brighton	Massachusetts
United States	Hudson Valley Audiology Center	New City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Epub 2004 Aug 1. — View Citation

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. — View Citation

Green CS, Bavelier D. Action video game modifies visual selective attention. Nature. 2003 May 29;423(6939):534-7. — View Citation

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. — View Citation

Keeling MD, Calhoun BM, Krüger 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. Epub 2007 Sep 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Nov 8. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Perception in Noise	Participants will report words spoken by a target speaker while several speakers serve as distractors.	up to 3 months	No
Secondary	Frequency Modulation Detection	We will measure the detectability of frequency excursions psychoacoustically.	up to 3 months	No
Secondary	Stroop Task	Participants will be asked to attend and report one feature of a stimulus while ignoring another	up to 3 months	No
Secondary	Letter-Numbers Sequencing Test	Participants are asked to repeat a string of letters and numbers.	up to 3 months	No

External Links

•   Laboratory website of Principal Investigator