Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old

Deaf Children Clinical Trial

Official title:

Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00140699
• Other study ID #: 2001.264
• Status: Active, not recruiting
• Phase: N/A
• First received: August 30, 2005
• Last updated: April 26, 2007

Study information

• Verified date: April 2007
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 (3/1000 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 (VVOR,VOR). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

Healthy group :

• Normal neurological status

• Normal visual status

• Normal ENT status

• TEOE present

• Informed consent aproved and signed

Sensorineural hearing loss group :

• Normal neurological status

• Normal visual status

• Otitis media or endocochlear hearing loss

• In the case of otitis, flat curve at tympanometry

• Transmissional aspect at BAERs

• Informed consent aproved and signed

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Deaf Children

Intervention

Behavioral:
• Balance

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France,