Developmental Reading DisorderDYS-AUTNCT00245804
Developmental Dyslexia and Functional Maturation of Auditory Cortex
An observational study of Developmental Reading Disorder and Dyslexia, run by University Hospital, Tours at 1 site in France.
Trial summary
Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. Read more about this study
- Who is it for?
- Ages 8 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Reading Disorder, Dyslexia
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2003to Feb 2005
- 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 8 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with developmental reading disorders from 8 to 25 jears. Control groupes with healthy people in de same age
Who may be able to join
- Age (8-10 years ; 11-17 years ; 18-25 years developmental reading disorders (developmental dyslexia) criteria according to Critchley (1970) PIQ > 85 No auditory deficit No psychosis -
Who cannot join
- PIQ < 85 Epilepsy ADHD Stroke, head injury
- -
Trial locations and contacts
1 site in 1 country.
About this study
Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different in developmental dyslexia and controls.
- Conditions
- Developmental Reading Disorder, Dyslexia
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult dyslexia | Adult dyslexia | |
| Minor-Dyslexia | Minor-Dyslexia | |
| Adult-Control | Adult-Control | |
| Minor-Control | Minor-Control |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startMar 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Reading DisorderStudies of the same condition, open and under way.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Caroline Hommet, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245804
- Sponsor's protocol ID
- PHRR02/CH/DYS-AUT
- Acronym
- DYS-AUT
- Status last verified
- Jan 2005
- First submitted
- 26 Oct 2005
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Dyslexia and Functional Maturation of Auditory Cortex
- ClinicalTrials.gov ID
- NCT00245804
- Acronym / sponsor ID
- DYS-AUT / PHRR02/CH/DYS-AUT
- Conditions
- Developmental Reading Disorder, Dyslexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Feb 2005
- First posted
- 28 Oct 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.
Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different in developmental dyslexia and controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult dyslexia | – | –Adult dyslexia |
| Minor-Dyslexia | – | –Minor-Dyslexia |
| Adult-Control | – | –Adult-Control |
| Minor-Control | – | –Minor-Control |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with developmental reading disorders from 8 to 25 jears. Control groupes with healthy people in de same age
Key inclusion criteria (1 listed)
- Age (8-10 years ; 11-17 years ; 18-25 years developmental reading disorders (developmental dyslexia) criteria according to Critchley (1970) PIQ > 85 No auditory deficit No psychosis -
Key exclusion criteria (2 listed)
- PIQ < 85 Epilepsy ADHD Stroke, head injury
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
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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.
Caroline Hommet principal investigator
University Hospital of Tours
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 Developmental Reading Disorder and Dyslexia, run by University Hospital, Tours 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jun 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 30 Jun 2010.