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Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization (SUN)

Primary Purpose

Hearing Loss, Unilateral

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fNIRS
Speech intelligibility
Sound localisation
Speech assessments
Quality of Life
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss, Unilateral focused on measuring Functional Neuroimaging, Pediatrics, fNIRS, Single-sided deafness

Eligibility Criteria

5 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

For both groups:

  • 5 to 16 year-old children,
  • Absence of pregnancy
  • Affiliation to Social Security, and children and their parents signed consents will be necessary.
  • Participation agreement of the protocol and signature of the consent form by the person having parental authority and the child

For Single-sided Deafness subjects:

- shall present with moderate to profound unilateral hearing loss, with a hearing loss of 40 decibel(minimal thresholds), assessed on tonal, vocal audiometry, Auditory Brainstem Responses,

For Normal hearing subjects:

- shall have normal hearing, demonstrated by air thresholds below 20 decibel by an audiometric control before inclusion , matched in gender and age to children in the experimental group

Exclusion Criteria:

For both groups:

  • Antecedents of Psycho-neurological diseases,
  • Other sensorineural or motor deficiency,
  • Familial bilingualism,
  • Medications affecting vigilance.
  • pregnancy or breastfeeding

Sites / Locations

  • Hôpital Pierre Paul Riquet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single-sided deaf group

Normal hearing group

Arm Description

30 children will be included in this group

30 children will be included in this group

Outcomes

Primary Outcome Measures

Oxyhemoglobin rates
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.
Deoxyhemoglobin rates
Deoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.

Secondary Outcome Measures

Binaural audiological performances
Speech in noise intelligibility and spatial sound localization ability
Speech assessment
Hearing perception thanks to Category of Auditory Performances - Nottingham Early Assessment Package 4 and speech intelligibility thanks to the Speech Intelligibility Rating - Nottingham Early Assessment Package 5
Quality of life scores
Quality of Life (QoL) evaluation will be based on the KindLR generic QoL scale. This scale exists in age specific modalities.
Quality of life scores
Quality of Life (QoL) evaluation will be based on scale, and the Speech Spatial and Qualities of hearing (SSQ) deafness specific scale. This scale exists in age specific modalities.
Activity levels
fNIRS measured cortical of activity levels

Full Information

First Posted
May 27, 2019
Last Updated
February 21, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT04043910
Brief Title
Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization
Acronym
SUN
Official Title
Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization in Unilateral Deaf Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Very difficult to include all patients
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to compare the auditory cortical activity in response to monaural and binaural stimuli, measured by functional Near-Infrared Spectroscopy (fNIRS) between Single-sided Deaf (SSD) Children, and Normal-Hearing (NH) children from 5 to 16 years. Binaural audiological performance, speech skills and quality of life (QoL) will be compared between the 2 groups and links to with the cortical activity will be assessed.
Detailed Description
Binaural hearing allows strengthening of speech intelligibility in noise and sound localization. It is well known that single-sided (SSD) and bilateral asymmetric deafness lead to socio-behavioral consequences and, in children, inducing impairments in learning acquisitions. In adults, SSD is associated with a reduction of inter-hemispheric functional asymmetry of auditory cortex on functional Magnetic Resonance Imaging. Moreover, in children with bilateral profound deafness who got one cochlear implant (inducing a form of asymmetric hearing), these clinical and functional anomalies cannot be overcome in case of a late (>1,5year) secondary implantation. This shows that once the loss of asymmetry is installed, it is difficult to recover from it. No data about SSD in children and its cortical representation exists. In this study, the investigators hypothesized that SSD modifies the auditory cortical activation profile, linked with a deterioration of the binaural auditory skills, the global development and the quality of life If this hypothesis is confirmed, systematic and individualized rehabilitation will be needed to reduce patient's handicap and to prevent long term consequences. The investigators will then measure the auditory cortical activity using fNIRS in 5 to 16 year-old SSD and NH children. The fNIRS system will use a sensor-bearing cap, measuring cortical activity through the scalp. Binaural hearing (speech in noise and localisation), speech assessments (global and speech development), and QoL will also be measured. Children will undergo 2 sessions of 1 to 2 hours tests, each spaced up to 3 months apart. As they are children regularly seen in our ear-nose-throat department, a once-a-year follow-up will be proposed, on the child and his family convenience. As it is a non-interventional study, no follow-up would be needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Unilateral
Keywords
Functional Neuroimaging, Pediatrics, fNIRS, Single-sided deafness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-sided deaf group
Arm Type
Experimental
Arm Description
30 children will be included in this group
Arm Title
Normal hearing group
Arm Type
Active Comparator
Arm Description
30 children will be included in this group
Intervention Type
Device
Intervention Name(s)
fNIRS
Intervention Description
The auditory cortical imaging will be performed by fNIRS measures. This non-invasive functional imaging technique relies on the use of a sensor-bearing cap, measuring cortical activity through scalp, during auditory stimulation. As head movement does not alter measurement that much, fNIRS is well adapted to children.
Intervention Type
Other
Intervention Name(s)
Speech intelligibility
Intervention Description
Speech intelligibility will be evaluated with French sentences comprehension in noise, from the Common Test or Adaptive Auditive Speech Test before 6 years, from the Common Test or Hearing in Noise Test for Children (Hint-C) from 7 to 11 years, and from the Hint-C or Marginal Benefit of Acoustic Amplification after 11 years, both with a Signal over Noise Ratio of +10 decibel at 65 decibel
Intervention Type
Other
Intervention Name(s)
Sound localisation
Intervention Description
Sound localisation will be evaluated with a left-right discrimination test before 7 years and a 12 loudspeakers sound localisation test after 7 years.
Intervention Type
Other
Intervention Name(s)
Speech assessments
Intervention Description
Speech assessments will be performed by dedicated speech therapists, with child age specific tests, and 2 global speech scores: the Category of Auditory Performances scale - second edition, and the Speech Intelligibility Rating scale.
Intervention Type
Other
Intervention Name(s)
Quality of Life
Intervention Description
Quality of Life (QoL) evaluation will be based on the generic QoL scale, and the Speech Spatial and Qualities of hearing (SSQ) deafness specific scale. Each scale exists in age specific modalities.
Primary Outcome Measure Information:
Title
Oxyhemoglobin rates
Description
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.
Time Frame
3 months
Title
Deoxyhemoglobin rates
Description
Deoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Binaural audiological performances
Description
Speech in noise intelligibility and spatial sound localization ability
Time Frame
3 months
Title
Speech assessment
Description
Hearing perception thanks to Category of Auditory Performances - Nottingham Early Assessment Package 4 and speech intelligibility thanks to the Speech Intelligibility Rating - Nottingham Early Assessment Package 5
Time Frame
3 months
Title
Quality of life scores
Description
Quality of Life (QoL) evaluation will be based on the KindLR generic QoL scale. This scale exists in age specific modalities.
Time Frame
3 months
Title
Quality of life scores
Description
Quality of Life (QoL) evaluation will be based on scale, and the Speech Spatial and Qualities of hearing (SSQ) deafness specific scale. This scale exists in age specific modalities.
Time Frame
3 months
Title
Activity levels
Description
fNIRS measured cortical of activity levels
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria : For both groups: 5 to 16 year-old children, Absence of pregnancy Affiliation to Social Security, and children and their parents signed consents will be necessary. Participation agreement of the protocol and signature of the consent form by the person having parental authority and the child For Single-sided Deafness subjects: - shall present with moderate to profound unilateral hearing loss, with a hearing loss of 40 decibel(minimal thresholds), assessed on tonal, vocal audiometry, Auditory Brainstem Responses, For Normal hearing subjects: - shall have normal hearing, demonstrated by air thresholds below 20 decibel by an audiometric control before inclusion , matched in gender and age to children in the experimental group Exclusion Criteria: For both groups: Antecedents of Psycho-neurological diseases, Other sensorineural or motor deficiency, Familial bilingualism, Medications affecting vigilance. pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Noëlle CAMELS
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pierre Paul Riquet
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization

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