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Completed

NCT Number: NCT04043910

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

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.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pierre Paul Riquet

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fNIRS

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

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

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

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

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.

Primary outcomes

  1. Oxyhemoglobin rates

    Time frame: 3 months

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

  2. Deoxyhemoglobin rates

    Time frame: 3 months

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

Secondary outcomes

  1. Binaural audiological performances

    Time frame: 3 months

    Speech in noise intelligibility and spatial sound localization ability

  2. Speech assessment

    Time frame: 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

  3. Quality of life scores

    Time frame: 3 months

    Quality of Life (QoL) evaluation will be based on the KindLR generic QoL scale. This scale exists in age specific modalities.

  4. Quality of life scores

    Time frame: 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.

  5. Activity levels

    Time frame: 3 months

    fNIRS measured cortical of activity levels

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study title

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

Acronym: SUN

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2019
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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