Listening EffortNCT03087045
Behavioral Manifestations of Listening Effort
An observational study of Listening Effort, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Listening Effort
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2017to 18 Mar 2017
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be selected from the University of Miami Ear Institute
Who may be able to join
- Normal Hearing
Who cannot join
- Do not meet inclusion criteria
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Otolaryngology
Miami, Florida, 33136
About this study
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.
Read the detailed description
Listening Effort has been described as a reflection of the cognitive resources necessary for speech understanding. Measures can broadly be classified into Subjective, Physiological and Behavioral measures of Listening Effort (LE). Subjective measures of LE involve the listener rating or answering a questionnaire on the presented auditory stimuli. Some examples of Subjective measures are the multidimensional speech, spatial and qualities (SSQ) scale and Listening effort rating scale. However, these measures suffer from individual bias, for example, what one person might find takes more effort, another might not.
Physiological measures establish relationships between changes in the central and/or autonomic nervous system activity and LE. Effect of LE on central nervous system activity include methods such as using Functional Magnetic Resonance Imaging (fMRI) to compare processing of noise vocoded versus clear sentence stimuli and using Electroencephalography (EEG) to monitor memory/cognitive load. Some methods of measuring effects on Autonomic Nervous system are through Pupillometry and Skin Conductance. Research has found that fluctuating pupil size may be an indicator of mental task load and/or attention, stress and memory. Furthermore, Pupillometric methods have been used to correlate changing measures like pupil size and listening tasks. There are some drawbacks of using pupillometry to measure LE- Absolute pupil size and change in pupil size for presented speech change according to the age of the listener. For instance, Older adults have been found to have smaller absolute pupil size and show lesser change in pupil size when moving from difficult to easier listening conditions. These drawbacks can be accounted for by normalizing the pupil size.
Behavioral measures take into account that the there is a decline in cognitive functions over prolonged mental effort used an auditory dual task paradigm where the primary task was word recognition and the secondary tasks were memory recall and Visual Response times. Apart from the Dual tasks, participants were also asked to assign a subjective rating based on SSQ. Findings revealed 1) that there is empirical evidence linking repeated instances of effortful listening and subsequent cognitive failure and 2) self- report measures did not show the same changes as the behavioral measures. It has been suggested that this may indicate that subjective (self-report) measures and behavioral measures assess separate aspects of fatigue. It may also be due to subjective measures having individual biases.
As mentioned above, there are numerous studies of subjective, objective and behavioral measures of LE, yet, there are no studies of the actual behavior employed by listeners to reduce listening effort. Further, researchers do not understand how these behaviors influence the ability of the listener to monitor and maintain conversational speech. Listeners must rely on both peripheral and central auditory mechanisms to process speech. As the auditory signal increases in complexity, likewise there is an increase in the auditory processing required to understand speech. The effort that the auditory system must put forth to process complex signals is even greater if the signal degraded or imbedded in competing signals such as background noise. This requires increased exertion and mental effort on the part of the listener, and results in a reduction in ability to maintain focus and an increase in fatigue. These issues are further amplified in the presence of a peripheral hearing disorder as listeners do not have the mechanisms required to properly process even simple and unchallenged auditory signals. Research has demonstrated decreasing word recognition accuracy with decreasing Signal to Noise Ratio (SNR) and demonstrated an increase in listening effort when speech was presented in increasingly negative SNRs. Numerous studies have reported on the increase in listening effort required for individuals with hearing loss.
The purpose of this investigation is quantify listening effort based subjective, objective and behavioral measures at different Signal to Noise Ratios (SNR).
- Conditions
- Listening Effort
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start13 Mar 2017
- Primary completion18 Mar 2017
- Study completion18 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Listening EffortStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hillary A Snapp, University of Miami
- Investigators
- Hillary Snapp, AuD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087045
- Sponsor's protocol ID
- 20170031
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7176597Noble 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.
PubMed 16579492Hick 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).
PubMed 12069009Hornsby 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.
PubMed 23426091Howard 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.
PubMed 21047295Kahneman D. 1973. Attention and Effort, New Jersey: Prentice-Hall Inc.
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.
PubMed 15532670Koelewijn 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.
PubMed 21921797Kramer 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.
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.
PubMed 23157603Laeng 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.
PubMed 26168419McGarrigle 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.
PubMed 24673660Picou 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.
PubMed 21498576Piquado 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.
PubMed 20070575Wild 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.
PubMed 23035108
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Manifestations of Listening Effort
- ClinicalTrials.gov ID
- NCT03087045
- Acronym / sponsor ID
- 20170031
- Conditions
- Listening Effort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 18 Mar 2017 (actual)
- Study completion
- 18 Mar 2017 (actual)
- First posted
- 22 Mar 2017 (actual)
- 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.
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.
Detailed description
Listening Effort has been described as a reflection of the cognitive resources necessary for speech understanding. Measures can broadly be classified into Subjective, Physiological and Behavioral measures of Listening Effort (LE). Subjective measures of LE involve the listener rating or answering a questionnaire on the presented auditory stimuli. Some examples of Subjective measures are the multidimensional speech, spatial and qualities (SSQ) scale and Listening effort rating scale. However, these measures suffer from individual bias, for example, what one person might find takes more effort, another might not.
Physiological measures establish relationships between changes in the central and/or autonomic nervous system activity and LE. Effect of LE on central nervous system activity include methods such as using Functional Magnetic Resonance Imaging (fMRI) to compare processing of noise vocoded versus clear sentence stimuli and using Electroencephalography (EEG) to monitor memory/cognitive load. Some methods of measuring effects on Autonomic Nervous system are through Pupillometry and Skin Conductance. Research has found that fluctuating pupil size may be an indicator of mental task load and/or attention, stress and memory. Furthermore, Pupillometric methods have been used to correlate changing measures like pupil size and listening tasks. There are some drawbacks of using pupillometry to measure LE- Absolute pupil size and change in pupil size for presented speech change according to the age of the listener. For instance, Older adults have been found to have smaller absolute pupil size and show lesser change in pupil size when moving from difficult to easier listening conditions. These drawbacks can be accounted for by normalizing the pupil size.
Behavioral measures take into account that the there is a decline in cognitive functions over prolonged mental effort used an auditory dual task paradigm where the primary task was word recognition and the secondary tasks were memory recall and Visual Response times. Apart from the Dual tasks, participants were also asked to assign a subjective rating based on SSQ. Findings revealed 1) that there is empirical evidence linking repeated instances of effortful listening and subsequent cognitive failure and 2) self- report measures did not show the same changes as the behavioral measures. It has been suggested that this may indicate that subjective (self-report) measures and behavioral measures assess separate aspects of fatigue. It may also be due to subjective measures having individual biases.
As mentioned above, there are numerous studies of subjective, objective and behavioral measures of LE, yet, there are no studies of the actual behavior employed by listeners to reduce listening effort. Further, researchers do not understand how these behaviors influence the ability of the listener to monitor and maintain conversational speech. Listeners must rely on both peripheral and central auditory mechanisms to process speech. As the auditory signal increases in complexity, likewise there is an increase in the auditory processing required to understand speech. The effort that the auditory system must put forth to process complex signals is even greater if the signal degraded or imbedded in competing signals such as background noise. This requires increased exertion and mental effort on the part of the listener, and results in a reduction in ability to maintain focus and an increase in fatigue. These issues are further amplified in the presence of a peripheral hearing disorder as listeners do not have the mechanisms required to properly process even simple and unchallenged auditory signals. Research has demonstrated decreasing word recognition accuracy with decreasing Signal to Noise Ratio (SNR) and demonstrated an increase in listening effort when speech was presented in increasingly negative SNRs. Numerous studies have reported on the increase in listening effort required for individuals with hearing loss.
The purpose of this investigation is quantify listening effort based subjective, objective and behavioral measures at different Signal to Noise Ratios (SNR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be selected from the University of Miami Ear Institute
Key inclusion criteria (1 listed)
- Normal Hearing
Key exclusion criteria (5 listed)
- Do not meet inclusion criteria
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate behavior modifications employed by listeners to optimize the signal to noise ratio and decrease listening effort in complex listening environments.
Time frame: One hour
We will evaluate compensatory strategies required by listeners to optimize listening in negative signal to noise ratios
Identify correlations in Listening effort measured using Pupillometry
Time frame: One hour
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
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 27 Apr 2023.
- Background: PubMed 7176597Downs 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.
- Background: PubMed 16579492Noble 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.
- Background: PubMed 12069009Hick 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).
- Background: PubMed 23426091Hornsby 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.
- Background: PubMed 21047295Howard 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.
- BackgroundKahneman D. 1973. Attention and Effort, New Jersey: Prentice-Hall Inc.
- Background: PubMed 15532670Killion 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.
- Background: PubMed 21921797Koelewijn 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.
- BackgroundKramer 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: PubMed 23157603Kuchinsky 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.
- Background: PubMed 26168419Laeng 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.
- Background: PubMed 24673660McGarrigle 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.
- Individual participant dataSharing planned: No
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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.
Hillary Snapp, AuD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Listening Effort, run by University of Miami at 1 site 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 1 inclusion and 5 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluate behavior modifications employed by listeners to optimize the signal to noise ratio and decrease listening effort in complex listening environments. (time frame: One hour). The study lists 2 primary outcomes in all. 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 NCT03087045, which also lists 17 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 27 Apr 2023.