Listening Effort in Cochlear Implant Users

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Brief Title

Listening Effort in Cochlear Implant Users

Official Title

Evaluation of Listening Effort With Pupillometry in Cochlear Implant Users

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.
    


Study Type

Interventional


Primary Outcome

Pupil dilatation (mm)

Secondary Outcome

 Speech intelligibility in quiet

Condition

Sensorineural Hearing Loss

Intervention

Pupillometry

Study Arms / Comparison Groups

 Pupillometry
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

16

Start Date

September 19, 2017

Completion Date

March 27, 2018

Primary Completion Date

March 27, 2018

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Isabelle Mosnier, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03212924

Organization ID

PIC_13


Responsible Party

Sponsor

Study Sponsor

Oticon Medical


Study Sponsor

Isabelle Mosnier, MD, Principal Investigator, Hôpital Pitié Sapêtrière - APHP


Verification Date

August 2018