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

Hearing Loss, Unilateral Clinical Trial

— SUN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04043910
• Other study ID #: RC31/17/0321
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: June 15, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Unilateral

Intervention

Device:
• 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.

Other:
• 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
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Pierre Paul Riquet	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxyhemoglobin rates	Oxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.	3 months
Primary	Deoxyhemoglobin rates	Deoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.	3 months
Secondary	Binaural audiological performances	Speech in noise intelligibility and spatial sound localization ability	3 months
Secondary	Speech assessment	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 months
Secondary	Quality of life scores	Quality of Life (QoL) evaluation will be based on the KindLR generic QoL scale. This scale exists in age specific modalities.	3 months
Secondary	Quality of life scores	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.	3 months
Secondary	Activity levels	fNIRS measured cortical of activity levels	3 months