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Listening Effort in Cochlear Implant Users

Primary Purpose

Sensorineural Hearing Loss, Cochlear Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pupillometry
Evaluation of speech comprehension in quiet
Evaluation of speech comprehension in noise
MOCA
auto evaluation of listening effort in quiet
auto evaluation of listening effort in noise
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring cochlear implant, Listening effort, pupillometry

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • informed consent
  • Native French speaker or fluent French speaker
  • Patient already fitted with one or two cochlear implants Oticon Medical
  • Can correctly identify at least 10 % of the words in monosyllabic Lafon lists in quiet
  • Normal or corrected to normal vision

Exclusion Criteria:

  • vulnerable patients (kids, pregnant women, persons under guardianship)
  • No Social security affiliation
  • blindness

Sites / Locations

  • Hôpital Pitié Salpêtrière - APHP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pupillometry

Arm Description

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise. Evaluation of speech comprehension in quiet Evaluation of speech comprehension in noise Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment) Auto evaluation of listening effort in quiet Auto evaluation of listening effort in noise

Outcomes

Primary Outcome Measures

Pupil dilatation (mm)
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. Measures of pupil dilatation are compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Amplitude of peak of pupil dilatation
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The amplitude of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Latency of peak of pupil dilatation (ms)
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The latency of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).

Secondary Outcome Measures

Speech intelligibility in quiet
percentage of phonemes correctly identify when the speech stimuli (monosyllabic words of Lafon) are presented in quiet at 65 dB SPL
Speech intelligibility in noise
percentage of phonemes correctly identify when the speech stimuli (monosyllabic words of Lafon) are presented in a wide band noise at 65 dB SPL with a +10 dB SNR (signal to noise ratio)
MOCA (Montreal Cognitive assessment)
Score at the MOCA. The maximum score is 30. The test suggests the existence of a cognitive impairment if the score is lower than 26.
VAS quiet
Auto evaluation of the listening effort in quiet with Visual Analog Scale. The participant has to indicate, on a continuous line, the listening effort used in the quiet condition. A score from 0 (no effort) to 10 (maximum effort) is extracted from the VAS.
VAS noise
Auto evaluation of the listening effort in quiet with Visual Analog Scale. The participant has to indicate, on a continuous line, the listening effort used in the noise condition. A score from 0 (no effort) to 10 (maximum effort) is extracted from the VAS.

Full Information

First Posted
July 6, 2017
Last Updated
August 21, 2018
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03212924
Brief Title
Listening Effort in Cochlear Implant Users
Official Title
Evaluation of Listening Effort With Pupillometry in Cochlear Implant Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, by monitoring the variations of pupil size in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (auto evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.
Detailed Description
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Most CI users can understand speech in quiet, but comprehension scores drop in the presence of background noise and in adverse conditions. Listening with a cochlear implant remains very demanding and most listeners report high levels of listening effort. The aim of current auditory prostheses and cochlear implants is not only restore speech understanding, but also to restore all the cognitive functions that are associated to a listening task (e.g., memory, executive functions, attention). Evaluating the listening effort is a new way to assess the efficiency of the hearing aids or cochlear implants. The listening effort indicates the amount of cognitive resources that are dedicated to a listening task; it evaluates also the cognitive resources remaining available for the other cognitive functions. The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, i. e. by measuring the pupil dilatation in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. Speech comprehension is measured for the two listening conditions and cognitive functions are assessed by the MOCA (Montreal Cognitive Assessment). In addition, the subjects are asked to subjectively evaluate the amount of listening effort they used in each listening situation. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (self evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Cochlear Hearing Loss
Keywords
cochlear implant, Listening effort, pupillometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pupillometry
Arm Type
Experimental
Arm Description
Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise. Evaluation of speech comprehension in quiet Evaluation of speech comprehension in noise Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment) Auto evaluation of listening effort in quiet Auto evaluation of listening effort in noise
Intervention Type
Behavioral
Intervention Name(s)
Pupillometry
Intervention Description
Measure of pupil dilatation simultaneously to the evaluation of speech intelligibility. The variation of the pupil size is monitored during the presentation of speech stimuli in quiet and in the presence of a background noise.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of speech comprehension in quiet
Intervention Description
Three lists of 17 monosyllabic words (Lafon) are presented in quiet at 65 dB SPL. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of speech comprehension in noise
Intervention Description
Three lists of 17 monosyllabic words (Lafon) are presented in a wide band noise at 65 dB SPL with a SNR (signal to noise ratio) of +10 dB. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified.
Intervention Type
Behavioral
Intervention Name(s)
MOCA
Other Intervention Name(s)
Montreal Cognitive Assessment
Intervention Description
The Montreal Cognitive Assessment (MoCA) is a screening instrument to detect cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points. The test suggests the existence of a cognitive impairment if the participant scores less than 26 points. The test is presented on a single sheet of paper.
Intervention Type
Behavioral
Intervention Name(s)
auto evaluation of listening effort in quiet
Other Intervention Name(s)
VAS (visual analog scale) in quiet
Intervention Description
The participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in quiet. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response.
Intervention Type
Behavioral
Intervention Name(s)
auto evaluation of listening effort in noise
Other Intervention Name(s)
VAS (visual analog scale) in noise
Intervention Description
The participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in the background noise. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response.
Primary Outcome Measure Information:
Title
Pupil dilatation (mm)
Description
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. Measures of pupil dilatation are compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Time Frame
1 hour
Title
Amplitude of peak of pupil dilatation
Description
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The amplitude of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Time Frame
1 hour
Title
Latency of peak of pupil dilatation (ms)
Description
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The latency of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Speech intelligibility in quiet
Description
percentage of phonemes correctly identify when the speech stimuli (monosyllabic words of Lafon) are presented in quiet at 65 dB SPL
Time Frame
30 mins simultaneously to pupillometry measures
Title
Speech intelligibility in noise
Description
percentage of phonemes correctly identify when the speech stimuli (monosyllabic words of Lafon) are presented in a wide band noise at 65 dB SPL with a +10 dB SNR (signal to noise ratio)
Time Frame
30 mins simultaneously to pupillometry measures
Title
MOCA (Montreal Cognitive assessment)
Description
Score at the MOCA. The maximum score is 30. The test suggests the existence of a cognitive impairment if the score is lower than 26.
Time Frame
15 mins
Title
VAS quiet
Description
Auto evaluation of the listening effort in quiet with Visual Analog Scale. The participant has to indicate, on a continuous line, the listening effort used in the quiet condition. A score from 0 (no effort) to 10 (maximum effort) is extracted from the VAS.
Time Frame
1 min
Title
VAS noise
Description
Auto evaluation of the listening effort in quiet with Visual Analog Scale. The participant has to indicate, on a continuous line, the listening effort used in the noise condition. A score from 0 (no effort) to 10 (maximum effort) is extracted from the VAS.
Time Frame
1 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed consent Native French speaker or fluent French speaker Patient already fitted with one or two cochlear implants Oticon Medical Can correctly identify at least 10 % of the words in monosyllabic Lafon lists in quiet Normal or corrected to normal vision Exclusion Criteria: vulnerable patients (kids, pregnant women, persons under guardianship) No Social security affiliation blindness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Mosnier, MD
Organizational Affiliation
Hôpital Pitié Sapêtrière - APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pitié Salpêtrière - APHP
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27355762
Citation
Kramer SE, Teunissen CE, Zekveld AA. Cortisol, Chromogranin A, and Pupillary Responses Evoked by Speech Recognition Tasks in Normally Hearing and Hard-of-Hearing Listeners: A Pilot Study. Ear Hear. 2016 Jul-Aug;37 Suppl 1:126S-35S. doi: 10.1097/AUD.0000000000000311.
Results Reference
result
PubMed Identifier
25668423
Citation
Steel MM, Papsin BC, Gordon KA. Binaural fusion and listening effort in children who use bilateral cochlear implants: a psychoacoustic and pupillometric study. PLoS One. 2015 Feb 10;10(2):e0117611. doi: 10.1371/journal.pone.0117611. eCollection 2015. Erratum In: PLoS One. 2015;10(10):e0141945.
Results Reference
result
PubMed Identifier
25654299
Citation
Winn MB, Edwards JR, Litovsky RY. The Impact of Auditory Spectral Resolution on Listening Effort Revealed by Pupil Dilation. Ear Hear. 2015 Jul-Aug;36(4):e153-65. doi: 10.1097/AUD.0000000000000145.
Results Reference
result
PubMed Identifier
21921797
Citation
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.
Results Reference
result
PubMed Identifier
24506437
Citation
Zekveld AA, Kramer SE. Cognitive processing load across a wide range of listening conditions: insights from pupillometry. Psychophysiology. 2014 Mar;51(3):277-84. doi: 10.1111/psyp.12151. Epub 2014 Feb 9.
Results Reference
result
PubMed Identifier
24999040
Citation
Zekveld AA, Heslenfeld DJ, Johnsrude IS, Versfeld NJ, Kramer SE. The eye as a window to the listening brain: neural correlates of pupil size as a measure of cognitive listening load. Neuroimage. 2014 Nov 1;101:76-86. doi: 10.1016/j.neuroimage.2014.06.069. Epub 2014 Jul 3.
Results Reference
result
PubMed Identifier
21233711
Citation
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.
Results Reference
result
PubMed Identifier
20588118
Citation
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.
Results Reference
result
PubMed Identifier
23275424
Citation
Pals C, Sarampalis A, Baskent D. Listening effort with cochlear implant simulations. J Speech Lang Hear Res. 2013 Aug;56(4):1075-84. doi: 10.1044/1092-4388(2012/12-0074). Epub 2012 Dec 28.
Results Reference
result

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Listening Effort in Cochlear Implant Users

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