Listening Effort in Cochlear Implant Users

NCT03212924 | Completed

• 1 other identifier: PIC_13
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss; Cochlear Hearing Loss

Keywords

cochlear implant; Listening effort; pupillometry

Outcome Measures

Primary Outcomes (3)

• 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).

  1 hour

• 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).

  1 hour

• 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).

  1 hour

Secondary Outcomes (5)

• 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

• VAS quiet

  1 min

• VAS noise

  1 min

Study Arms (1)

Pupillometry

EXPERIMENTAL

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

Behavioral: Pupillometry; Behavioral: Evaluation of speech comprehension in quiet; Behavioral: Evaluation of speech comprehension in noise; Behavioral: MOCA; Behavioral: auto evaluation of listening effort in quiet; Behavioral: auto evaluation of listening effort in noise

Interventions

Pupillometry BEHAVIORAL

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.

Pupillometry

Evaluation of speech comprehension in quiet BEHAVIORAL

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.

Pupillometry

Evaluation of speech comprehension in noise BEHAVIORAL

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.

Pupillometry

MOCA BEHAVIORAL

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.

Also known as: Montreal Cognitive Assessment

Pupillometry

auto evaluation of listening effort in quiet BEHAVIORAL

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.

Also known as: VAS (visual analog scale) in quiet

Pupillometry

auto evaluation of listening effort in noise BEHAVIORAL

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.

Also known as: VAS (visual analog scale) in noise

Pupillometry

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Hôpital Pitié Salpêtrière - APHP

Paris, 75013, France

Location

Related Publications (9)

• 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.

  PMID: 27355762 RESULT

• 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.

  PMID: 25668423 RESULT

• 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.

  PMID: 25654299 RESULT

• 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.

  PMID: 21921797 RESULT

• 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.

  PMID: 24506437 RESULT

• 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.

  PMID: 24999040 RESULT

• 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.

  PMID: 21233711 RESULT

• 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.

  PMID: 20588118 RESULT

• 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.

  PMID: 23275424 RESULT

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Noise; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Isabelle Mosnier, MD

  Hôpital Pitié Sapêtrière - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: September 19, 2017
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)