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Clinical Trials/NCT03212924
NCT03212924
Completed
N/A

Evaluation of Listening Effort With Pupillometry in Cochlear Implant Users

Oticon Medical1 site in 1 country16 target enrollmentSeptember 19, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sensorineural Hearing Loss
Sponsor
Oticon Medical
Enrollment
16
Locations
1
Primary Endpoint
Latency of peak of pupil dilatation (ms)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2017
End Date
March 27, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Latency of peak of pupil dilatation (ms)

Time Frame: 1 hour

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).

Amplitude of peak of pupil dilatation

Time Frame: 1 hour

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).

Pupil dilatation (mm)

Time Frame: 1 hour

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).

Secondary Outcomes

  • VAS quiet(1 min)
  • VAS noise(1 min)
  • Speech intelligibility in quiet(30 mins simultaneously to pupillometry measures)
  • Speech intelligibility in noise(30 mins simultaneously to pupillometry measures)
  • MOCA (Montreal Cognitive assessment)(15 mins)

Study Sites (1)

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