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