Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140699
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2005-08-30
Brief Title:
Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Balance disorders in children are poorly known underestimated and rarely assessed Technologies to assess balance in children are almost non-existent apart from a few exceptions Such technologies are routinely used in adults for some decades and are of considerable contribution in the diagnosis and treatment of adults balance disorders
The aim of this study is
1 to assess objectively children balance disorders
2 to provide technologies suitable for children balance assessement
3 to study children balance disorders suffering from sensorineural hearing loss
The aim of this study is
1 to assess objectively children balance disorders
2 to provide technologies suitable for children balance assessement
3 to study children balance disorders suffering from sensorineural hearing loss
Detailed Description:
The inner ear included two sensorineural organs closely linked the cochlea and the vestibule With regards to children inner ear affliction only cochlear function is taken into consideration whereas balance related to vestibule function is often neglected
Congenital sensorineural hearing loss is frequent 31000 births Martin et al 1981 Fortum et al 1997 Furthermore otitis media is among the most frequent afflictions discovered in small childhood and Handicaps secondary to sensorineural hearing loss are numerous language cognitive disorders delay according to school and social integration Joint Commitee on Infant Hearing 1994 Casselbrant et al 2005 Jung et al 2005
In counterpart children balance disorders are often unknown and underestimated However they clinically lead to an evident handicap in case of acute or chronic otitis media Caselbrant et al 1995 Balance control involves three sensory systems tightly linked vision vestibule and somesthesia From the links between vision and vestibule originate the visio-vestibular and vestibulo-ocular reflexes VVORVOR Dynamic Posturography DP is a technology able to measure each of these sensory inputs involved in balance control by recording sensory organization test SOT This technology is available for adults for a few decades but are poorly used in children Wiener-Vacher et al 1996 1998 Casselbrant et al 1995 2005
Aims
1-To assess objectively children balance control to provide normative data according to the age 2- to put in place methods to investigate children balance disorders 3- to study children balance disorders suffering from sensorineural hearing loss
Methods
Studied population two groups of children are involved and compared in this study 150 healthy children and 150 children suffering from sensorineural hearing loss Each group is divided into three age groups 6-8 8-10 10-12 years old
Assessment
The following parameters are recorded in both groups VVOR and VOR SOT on two DP Equitest and Balance Quest Transient Evoked Otoacoustic Emissions were recorded too in order to prove normal hearing status in the healthy group and hearing loss in the sensorineural hearing loss group
Congenital sensorineural hearing loss is frequent 31000 births Martin et al 1981 Fortum et al 1997 Furthermore otitis media is among the most frequent afflictions discovered in small childhood and Handicaps secondary to sensorineural hearing loss are numerous language cognitive disorders delay according to school and social integration Joint Commitee on Infant Hearing 1994 Casselbrant et al 2005 Jung et al 2005
In counterpart children balance disorders are often unknown and underestimated However they clinically lead to an evident handicap in case of acute or chronic otitis media Caselbrant et al 1995 Balance control involves three sensory systems tightly linked vision vestibule and somesthesia From the links between vision and vestibule originate the visio-vestibular and vestibulo-ocular reflexes VVORVOR Dynamic Posturography DP is a technology able to measure each of these sensory inputs involved in balance control by recording sensory organization test SOT This technology is available for adults for a few decades but are poorly used in children Wiener-Vacher et al 1996 1998 Casselbrant et al 1995 2005
Aims
1-To assess objectively children balance control to provide normative data according to the age 2- to put in place methods to investigate children balance disorders 3- to study children balance disorders suffering from sensorineural hearing loss
Methods
Studied population two groups of children are involved and compared in this study 150 healthy children and 150 children suffering from sensorineural hearing loss Each group is divided into three age groups 6-8 8-10 10-12 years old
Assessment
The following parameters are recorded in both groups VVOR and VOR SOT on two DP Equitest and Balance Quest Transient Evoked Otoacoustic Emissions were recorded too in order to prove normal hearing status in the healthy group and hearing loss in the sensorineural hearing loss group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None