AzTrials
AzTrials

Deaf ChildrenNCT00140699

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

An observational study of Deaf Children, run by Hospices Civils de Lyon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Deaf Children
What is being tested?
Balance
How many people
240 participants
Where
1 siteFrance
Study dates
Start not givento not given
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • Child

Who may be able to join

  • Healthy group :
  • Normal neurological status
  • Normal visual status
  • Normal ENT status
  • TEOE present
  • Informed consent aproved and signed
Show all 13Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69395

Other trials in France

About this study

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.
Read the 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 (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.

Conditions
Deaf Children
Being tested
Balance
Keywords
Children, Hearing loss, Balance control, Sensory inputs
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BalanceBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2005 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140699
Sponsor's protocol ID
2001.264
Status last verified
Apr 2007
First submitted
30 Aug 2005
Last updated
27 Apr 2007
Results posted
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in