NCT03087045

Brief Summary

The purpose of this investigation is to investigate the behavioral manifestations of listening effort. Quantifying listening effort based on an easy to measure behavioral metric would allow for better understanding of the effort that goes into processing conversational speech. The investigators hypothesize that the behavior modifications required to improve the signal to noise ratio in increasingly complex listening environments significantly deviates from quiet listening environments. Further, the investigators hypothesize that this directly contributes to increased listening effort and reduced ability to accurately monitor content for everyday conversation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 13, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

5 days

First QC Date

March 16, 2017

Last Update Submit

April 25, 2023

Conditions

Listening Effort

Outcome Measures

Primary Outcomes (2)

  • Evaluate behavior modifications employed by listeners to optimize the signal to noise ratio and decrease listening effort in complex listening environments.

    We will evaluate compensatory strategies required by listeners to optimize listening in negative signal to noise ratios

    One hour

  • Identify correlations in Listening effort measured using Pupillometry

    Pupillometry has been shown to be an accurate objective measure of listening effort. We will compare the behavioral responses of increased listening effort to physiologic response as measured by change in pupil size

    One hour

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be selected from the University of Miami Ear Institute

You may qualify if:

  • Normal Hearing

You may not qualify if:

  • Pregnant women
  • Prisoners
  • Does not speak English
  • Those displaying cognitive impairment (Potential study subjects will be screened for potential cognitive impairments that may negatively influence control data. We will use the validated mini mental exam)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Department of Otolaryngology

Miami, Florida, 33136, United States

Location

Related Publications (17)

  • Downs DW. Effects of hearing and use on speech discrimination and listening effort. J Speech Hear Disord. 1982 May;47(2):189-93. doi: 10.1044/jshd.4702.189.

    PMID: 7176597BACKGROUND

  • Noble W, Gatehouse S. Effects of bilateral versus unilateral hearing aid fitting on abilities measured by the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Int J Audiol. 2006 Mar;45(3):172-81. doi: 10.1080/14992020500376933.

    PMID: 16579492BACKGROUND

  • Hick CB, Tharpe AM. Listening effort and fatigue in school-age children with and without hearing loss. J Speech Lang Hear Res. 2002 Jun;45(3):573-84. doi: 10.1044/1092-4388(2002/046).

    PMID: 12069009BACKGROUND

  • Hornsby BW. The effects of hearing aid use on listening effort and mental fatigue associated with sustained speech processing demands. Ear Hear. 2013 Sep;34(5):523-34. doi: 10.1097/AUD.0b013e31828003d8.

    PMID: 23426091BACKGROUND

  • Howard CS, Munro KJ, Plack CJ. Listening effort at signal-to-noise ratios that are typical of the school classroom. Int J Audiol. 2010 Dec;49(12):928-32. doi: 10.3109/14992027.2010.520036. Epub 2010 Nov 4.

    PMID: 21047295BACKGROUND

  • Kahneman D. 1973. Attention and Effort, New Jersey: Prentice-Hall Inc.

    BACKGROUND

  • Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440.

    PMID: 15532670BACKGROUND

  • Koelewijn T, Zekveld AA, Festen JM, Kramer SE. Pupil dilation uncovers extra listening effort in the presence of a single-talker masker. Ear Hear. 2012 Mar-Apr;33(2):291-300. doi: 10.1097/AUD.0b013e3182310019.

    PMID: 21921797BACKGROUND

  • Kramer S.E., Lorens A., Coninx F., Zekveld A.A., Piotrowska A. et al. Processing load during listening: The influence of task characteristics on the pupil response. Lang Cognitive Proc, 2012. 28: p.426 - 442.

    BACKGROUND

  • Kuchinsky SE, Ahlstrom JB, Vaden KI Jr, Cute SL, Humes LE, Dubno JR, Eckert MA. Pupil size varies with word listening and response selection difficulty in older adults with hearing loss. Psychophysiology. 2013 Jan;50(1):23-34. doi: 10.1111/j.1469-8986.2012.01477.x. Epub 2012 Nov 15.

    PMID: 23157603BACKGROUND

  • Laeng B, Sirois S, Gredeback G. Pupillometry: A Window to the Preconscious? Perspect Psychol Sci. 2012 Jan;7(1):18-27. doi: 10.1177/1745691611427305. Epub 2012 Jan 5.

    PMID: 26168419BACKGROUND

  • McGarrigle R, Munro KJ, Dawes P, Stewart AJ, Moore DR, Barry JG, Amitay S. Listening effort and fatigue: what exactly are we measuring? A British Society of Audiology Cognition in Hearing Special Interest Group 'white paper'. Int J Audiol. 2014 Jul;53(7):433-40. doi: 10.3109/14992027.2014.890296. Epub 2014 Mar 27.

    PMID: 24673660BACKGROUND

  • Picou EM, Ricketts TA, Hornsby BW. Visual cues and listening effort: individual variability. J Speech Lang Hear Res. 2011 Oct;54(5):1416-30. doi: 10.1044/1092-4388(2011/10-0154). Epub 2011 Apr 15.

    PMID: 21498576BACKGROUND

  • Piquado T, Isaacowitz D, Wingfield A. Pupillometry as a measure of cognitive effort in younger and older adults. Psychophysiology. 2010 May 1;47(3):560-9. doi: 10.1111/j.1469-8986.2009.00947.x. Epub 2010 Jan 11.

    PMID: 20070575BACKGROUND

  • Wild CJ, Yusuf A, Wilson DE, Peelle JE, Davis MH, Johnsrude IS. Effortful listening: the processing of degraded speech depends critically on attention. J Neurosci. 2012 Oct 3;32(40):14010-21. doi: 10.1523/JNEUROSCI.1528-12.2012.

    PMID: 23035108BACKGROUND

  • Zekveld AA, Kramer SE, Festen JM. Pupil response as an indication of effortful listening: the influence of sentence intelligibility. Ear Hear. 2010 Aug;31(4):480-90. doi: 10.1097/AUD.0b013e3181d4f251.

    PMID: 20588118BACKGROUND

  • Zekveld AA, Kramer SE, Festen JM. Cognitive load during speech perception in noise: the influence of age, hearing loss, and cognition on the pupil response. Ear Hear. 2011 Jul-Aug;32(4):498-510. doi: 10.1097/AUD.0b013e31820512bb.

    PMID: 21233711BACKGROUND

Study Officials

  • Hillary Snapp, AuD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 22, 2017

Study Start

March 13, 2017

Primary Completion

March 18, 2017

Study Completion

March 18, 2017

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)