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

Toulouse University Hospital

Status: Terminated

Conditions: Hearing Loss, Unilateral

Treatments: Device: fNIRS; Other: Speech assessments; Other: Sound localisation; Other: Quality of Life; Other: Speech intelligibility

Study type: Interventional

Funder types: Other

Identifiers

NCT04043910

RC31/17/0321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Single-sided deaf group

Experimental group

Description:

30 children will be included in this group

Treatment:

Other: Speech intelligibility

Other: Sound localisation

Device: fNIRS

Other: Speech assessments

Other: Quality of Life

Normal hearing group

Active Comparator group

Description:

30 children will be included in this group

Treatment:

Other: Speech intelligibility

Other: Sound localisation

Device: fNIRS

Other: Speech assessments

Other: Quality of Life