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Spatial Hearing Perception in Bilateral Cochlear Implant Children (SPHERIC1)

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ClinicalTrials.gov Identifier: NCT03738592
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no studies have explored yet spatial auditory perception in three-dimensional space (3D). Moreover auditory rehabilitation after cochlear implantation is totally devoted to speech rehabilitation to date.

A novel methodology based on virtual reality and 3D motion capture protocol in an immersive reality system has recently been developed to evaluate and record spatial hearing abilities of norm-hearing (NH) listeners and CI adults in 3D. The results revealed worse sound localization in 3D for CI users compared to NH participants, and interestingly noted that head movements could improve sound localization performances, leading to a possible track for auditory rehabilitation.

The aim of this study is to explore spatial hearing in CI children with the protocol already tested in CI adults. This protocol will be adapted to children over eight years old. Children will have to perform a sound localization task in 3D without any feedback of performances. The knowledge improvement in pediatric sound localization will lead to develop a specific spatial rehabilitation in cochlear implant children.


Condition or disease Intervention/treatment Phase
Cochlear Impant Children Other: behavioral exploration of spatial hearing performances Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents) Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Spatial Hearing Perception in Bilateral Cochlear Implant Children
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : February 24, 2021
Estimated Study Completion Date : February 24, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cochlear implant children
18 cochlear implant children wil include in this study
Other: behavioral exploration of spatial hearing performances

Normal hearing children and cochlear implant children will have to localize a sound source in three dimensional space by using a virtual reality system (Neuro immersion platform). The experiment will last thirty minutes.

For normal hearing children, this experience will be performed at the inclusion visit.

For cochlear implant children, this experience will be performed 28 days (+/- 2 days) after inclusion.


Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents)

For cochlear implant children and their parents, a SSQ questionnaire will be given and completed during the first visit (at the inclusion).

This questionnaire offers a version for parents of children with hearing loss ("SSQ Parents CI") and a version for the children themselves ("SSQ Children CI").


Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)

The SSQ questionnaire for Parents of CI children is composed of three distinct sections (A, B and C).

Each section will be filled separately by parents of CI children with one of the study collaborators during 3 telephone calls spaced 1 week apart. Thus, section A will be completed 7 days (+/- 2 days) after inclusion , section B 14 days (+/- 2 days) after inclusion, and section C 21 days (+/- 2 days) after inclusion.


normal hearing children
18 normal hearing children wil include in this study
Other: behavioral exploration of spatial hearing performances

Normal hearing children and cochlear implant children will have to localize a sound source in three dimensional space by using a virtual reality system (Neuro immersion platform). The experiment will last thirty minutes.

For normal hearing children, this experience will be performed at the inclusion visit.

For cochlear implant children, this experience will be performed 28 days (+/- 2 days) after inclusion.





Primary Outcome Measures :
  1. measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space [ Time Frame: thirty minutes ]
    Data from spatial sound perception will be recorded in three dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "D", hence summarizing all three dimensions of space, and taking into account absolute and variable error in one measure.


Secondary Outcome Measures :
  1. measure of head and eye movements in three dimensional space with a motion tracking system (virtual reality system including a Head-Mounted display) to evaluate their roles in spatial hearing performances. [ Time Frame: thirty minutes ]
    Head and eye movements will be recorded in three dimensional space with a motion tracking system (virtual reality system including a Head-Mounted display). The cumulative error "D" will be calculated in two different conditions: first, participant's head will be fixed during sound emission and then, head and eyes will be free to move. If the cumulative error "D" significantly decreases when head movements are free, we could say that head movements allow/help improving spatial hearing performances.

  2. impact of age at cochlear implantation on spatial hearing deficit [ Time Frame: thirty minutes ]
    spatial hearing deficit will be correlated to the age at cochlear implantation

  3. change of the pupil diameter during a sound localization task [ Time Frame: thirty minutes ]
    Pupil diameter will be recorded with an eye tracking system during all experiment

  4. correlation between a clinical score (SSQ) and sound localization performances [ Time Frame: 28 days ]
    The SSQ questionnaire is a clinical subjective scale adapted to parents and cochlear implant children. It allows evaluating hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten. For example, a zero score corresponds to bad hearing abilities. We will therefore correlate the mean score of all questions out of ten to the cumulative error "D".



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for cochlear implant children:

  • Age between 8 and 17 included
  • second cochlear implant issued within more than 2 years
  • mean speech recognition over 80% with two cochlear implants
  • normal visual acuity with or without correction
  • abilities to understand experimental instructions
  • a consent form signed by parents or guardian
  • registered with a social security scheme

Exclusion Criteria for cochlear implant children:

  • neurologic or psychiatric trouble
  • visual trouble
  • bilateral vestibular areflexia

Inclusion Criteria for normal hearing children:

  • Age between 8 and 17 included
  • normal visual acuity with or without correction
  • abilities to understand experimental instructions
  • a consent form signed by parents or guardian
  • registered with a social security scheme

Exclusion Criteria for normal hearing children:

  • neurologic or psychiatric trouble
  • visual trouble
  • bilateral vestibular areflexia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738592


Contacts
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Contact: Eric TRUY, PUPH 04 72 11 04 92 ext +33 eric.truy@chu-lyon.fr
Contact: Valérie GAVEAU, PhD 04 72 91 34 10 ext +33 valerie.gaveau@inserm.fr

Locations
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France
Centre de Recherche en Neuroscience de Lyon (CRNL) Recruiting
Bron, France, 69676
Contact: Valérie GAVEAU, PhD    04 72 91 34 10 ext +33    valerie.gaveau@inserm.fr   
Principal Investigator: Eric TRUY, PUPH         
Hôpital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Eric TRUY, PUPH    04 72 11 04 92 ext +33    eric.truy@chu-lyon.fr   
Principal Investigator: Eric TRUY, PUPH         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Eric TRUY, PUPH Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03738592     History of Changes
Other Study ID Numbers: 69HCL18_0471
2018-A02509-46 ( Other Identifier: ID-RCB )
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
spatial hearing perception
cochlear implant
child
virtual reality