Listening Effort in Cochlear Implant Users

NCT03212924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-22

No results posted yet for this study

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.

Conditions

  • Sensorineural Hearing Loss
  • Cochlear Hearing Loss

Interventions

BEHAVIORAL

Pupillometry

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.

BEHAVIORAL

Evaluation of speech comprehension in quiet

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.

BEHAVIORAL

Evaluation of speech comprehension in noise

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.

BEHAVIORAL

MOCA

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.

BEHAVIORAL

auto evaluation of listening effort in quiet

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.

BEHAVIORAL

auto evaluation of listening effort in noise

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.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Isabelle Mosnier, MD · Hôpital Pitié Sapêtrière - APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2018-03-27
Completion
2018-03-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212924 on ClinicalTrials.gov