Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization
- Conditions
- Hearing Loss, Unilateral
- Interventions
- Device: fNIRSOther: Speech intelligibilityOther: Sound localisationOther: Speech assessmentsOther: Quality of Life
- Registration Number
- NCT04043910
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
Not provided
For both groups:
- Antecedents of Psycho-neurological diseases,
- Other sensorineural or motor deficiency,
- Familial bilingualism,
- Medications affecting vigilance.
- pregnancy or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal hearing group fNIRS 30 children will be included in this group Single-sided deaf group Sound localisation 30 children will be included in this group Single-sided deaf group fNIRS 30 children will be included in this group Single-sided deaf group Speech intelligibility 30 children will be included in this group Normal hearing group Sound localisation 30 children will be included in this group Normal hearing group Speech intelligibility 30 children will be included in this group Normal hearing group Speech assessments 30 children will be included in this group Single-sided deaf group Speech assessments 30 children will be included in this group Single-sided deaf group Quality of Life 30 children will be included in this group Normal hearing group Quality of Life 30 children will be included in this group
- Primary Outcome Measures
Name Time Method Oxyhemoglobin rates 3 months Oxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.
Deoxyhemoglobin rates 3 months Deoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.
- Secondary Outcome Measures
Name Time Method Binaural audiological performances 3 months Speech in noise intelligibility and spatial sound localization ability
Speech assessment 3 months 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 3 months 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 3 months fNIRS measured cortical of activity levels
Trial Locations
- Locations (1)
Hôpital Pierre Paul Riquet
🇫🇷Toulouse, France