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

NCT ID: NCT04043910

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2022-06-15

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.

Conditions

Hearing Loss, Unilateral

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single-sided deaf group

30 children will be included in this group

Group Type: EXPERIMENTAL

fNIRS

Intervention Type: DEVICE

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.

Speech intelligibility

Intervention Type: OTHER

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

Sound localisation

Intervention Type: OTHER

Sound localisation will be evaluated with a left-right discrimination test before 7 years and a 12 loudspeakers sound localisation test after 7 years.

Speech assessments

Intervention Type: OTHER

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.

Quality of Life

Intervention Type: OTHER

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.

Normal hearing group

30 children will be included in this group

Group Type: ACTIVE_COMPARATOR

fNIRS

Intervention Type: DEVICE

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.

Speech intelligibility

Intervention Type: OTHER

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

Sound localisation

Intervention Type: OTHER

Sound localisation will be evaluated with a left-right discrimination test before 7 years and a 12 loudspeakers sound localisation test after 7 years.

Speech assessments

Intervention Type: OTHER

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.

Quality of Life

Intervention Type: OTHER

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.

Interventions

fNIRS

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: DEVICE

Speech intelligibility

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

Sound localisation

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

Speech assessments

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

Quality of Life

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Noëlle CAMELS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Hôpital Pierre Paul Riquet

Toulouse, , France

Countries

France

Other Identifiers

RC31/17/0321

Identifier Type: -

Identifier Source: org_study_id