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.
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
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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.
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 :
- to assess objectively children balance disorders.
- to provide technologies suitable for children balance assessement.
- 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.
- First posted1 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deaf ChildrenStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Chantal Ferber-Viart, MD, PhD, Principal investigator, Hospices Civils de Lyon
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old
- ClinicalTrials.gov ID
- NCT00140699
- Acronym / sponsor ID
- 2001.264
- Conditions
- Deaf Children
- Keywords
- Children, Hearing loss, Balance control, Sensory inputs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- to assess objectively children balance disorders.
- to provide technologies suitable for children balance assessement.
- 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 (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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (13 listed)
- Normal neurological status
- Normal visual status
- Normal ENT status
- TEOE present
- Informed consent aproved and signed
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Ferber-Viart, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deaf Children, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2007.