Skip to content

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

Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization in Unilateral Deaf Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04043910
Acronym
SUN
Enrollment
50
Registered
2019-08-02
Start date
2018-04-17
Completion date
2022-06-15
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Unilateral

Keywords

Functional Neuroimaging, Pediatrics, fNIRS, Single-sided deafness

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.

Interventions

DEVICEfNIRS

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.

OTHERSpeech 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

OTHERSound 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.

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.

OTHERQuality 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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER
Centre National de la Recherche Scientifique, France
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Oxyhemoglobin rates3 monthsOxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.
Deoxyhemoglobin rates3 monthsDeoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.

Secondary

MeasureTime frameDescription
Binaural audiological performances3 monthsSpeech in noise intelligibility and spatial sound localization ability
Speech assessment3 monthsHearing 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 scores3 monthsQuality of Life (QoL) evaluation will be based on the KindLR generic QoL scale. This scale exists in age specific modalities.
Activity levels3 monthsfNIRS measured cortical of activity levels

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarie-Noëlle CAMELS

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026