- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05091983
Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (ODYSSED)
Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (Orality Dysensoriality and Eating Disorder)
Study Overview
Status
Detailed Description
Eating disorders are a frequent reason for consultation in pediatrics at all ages.
When they are small, children may have an orality disorder. There are multiple potential causes for this disorder: psychogenic, oropraxic but also sensory. The treatment is then adapted to the patient, with, among other things, an orientation towards professionals trained in sensory disorders.
As they grow up, adolescents are particularly at risk of developing eating disorders, which are pathologies that correspond to a biopsychosocial model of understanding that includes psychogenetic, neuroendocrine and immune factors.
Despite major advances in the understanding of this disease, the sensory dimension for these patients is still little studied and is not taken into account in the treatment proposed to adolescents suffering from eating disorders.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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IDF
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Paris, IDF, France, 75014
- Maison de Solenn Maison des Adolescents, Cochin Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adolescent between 12 to 18 years old.
- Non-opposition of the adolescent and his or her legal guardians collected before the start of the study.
- Patient group: Diagnosis of restrictive eating disorders (Anorexia Nervosa typical or atypical, ARFID) meeting DSM-5 criteria.
- Control group: absence of eating disorders.
Exclusion Criteria:
- Eating disorders secondary to another psychiatric pathology.
- Precarious health status with somatic and/or psychiatric instability that does not allow to answer the questionnaire.
- Language barrier.
- Opposition of the adolescent and/or his/her legal representatives obtained before the start of the study
- Patient under " AME " (medical state help)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Restrictive eating disorder group
Adolescents between 12 and 18 y.o.
Restrictive eating disorders diagnosis (Anorexia Nervosa or ARFID) answering DSM-5 criteria
|
The Sensory Processing Scale Inventory (SPSI) is the main questionnaire.
It allows to define over and under sensitive profiles.
It's a self-administrated questionnaire
The ASSQ allows to detect autism spectrum disorders (ASD). This quotient is proposed to the group because the investigators know that ASD are often correlated with sensory integration disorders. It's answered by the participant's parents. The GAD7 questionnaire allows to detect anxiety disorder. This questionnaire is proposed to the group because the investigators know that anxiety disorders are often correlated with sensory integration disorders. It's a self-administrated questionnaire. The Conners abridged questionnaire allows to detect attention-deficit hyperactivity disorder (ADHD). This questionnaire is proposed to the group because the investigators know that ADHD are often correlated with sensory integration disorders. The questionnaire is answered by the participant's parents. The EAT 26 questionnaire allows to detect anorexia nervosa. It is proposed to the patient with an eating disorder to establish the level of severity of their disease. It's a self-administrated questionnaire. |
Control group
Adolescents between 12 and 18 y.o.
No eating disorders
|
The Sensory Processing Scale Inventory (SPSI) is the main questionnaire.
It allows to define over and under sensitive profiles.
It's a self-administrated questionnaire
The ASSQ allows to detect autism spectrum disorders (ASD). This quotient is proposed to the group because the investigators know that ASD are often correlated with sensory integration disorders. It's answered by the participant's parents. The GAD7 questionnaire allows to detect anxiety disorder. This questionnaire is proposed to the group because the investigators know that anxiety disorders are often correlated with sensory integration disorders. It's a self-administrated questionnaire. The Conners abridged questionnaire allows to detect attention-deficit hyperactivity disorder (ADHD). This questionnaire is proposed to the group because the investigators know that ADHD are often correlated with sensory integration disorders. The questionnaire is answered by the participant's parents. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Sensory Processing Scale Inventory (SPSI) scores between the two groups
Time Frame: Inclusion
|
Comparison of average Sensory Processing Scale Inventory (SPSI) scores between the two groups This questionnaire focuses on sensoriality. It allows the definition of over or under-reactive sensory profiles. It is made of two lists (list #1 : 73 items ; list #2 : 29 items). The SPSI questionnaire is in English. For this reason, a group of experts from La Maison de Solenn met to translate it into French being as faithful as possible to the original questionnaire. Each checklist has its own score, the result is the sum of the points obtained (one point for YES, zero points for NO) (6). Two groups will be formed: a group with eating disorders and a control group. The questionnaire will be answered only once and will be proposed to the participant at the end of a consultation at the Maison de Solenn for his usual follow-up or during a hospitalization (full time hospitalization or in day hospital). |
Inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening for pathologies known to be associated with a sensory disorder
Time Frame: Inclusion
|
Screening questionnaires for Autism Spectrum Disorder (ASD) will be distributed in order to identify disorders associated with a particular sensory profile.
This will allow statistical results to be refined by performing multivariate analyses.
|
Inclusion
|
Screening for pathologies known to be associated with a sensory disorder
Time Frame: Inclusion
|
Screening questionnaires for Attention Deficit Hyperactivity Disorder (ADHD) will be distributed in order to identify disorders associated with a particular sensory profile.
This will allow statistical results to be refined by performing multivariate analyses.
|
Inclusion
|
Screening for pathologies known to be associated with a sensory disorder
Time Frame: Inclusion
|
Screening questionnaires for Generalized Anxiety Disorder (GAD) will be distributed in order to identify disorders associated with a particular sensory profile.
This will allow statistical results to be refined by performing multivariate analyses.
|
Inclusion
|
Search for a link between the eating disorders severity and sensory disorders
Time Frame: Inclusion
|
The EAT 26 questionnaire is used to measure the severity of an eating disorder. It will be proposed only to the participants of the eating disorder group. This measure of severity will assess whether there is a relationship between the severity of the ED and the severity of the sensory disorders. |
Inclusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Corinne BLANCHET, APHP - Cochin hospital
Publications and helpful links
General Publications
- Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
- Gorwood P, Blanchet-Collet C, Chartrel N, Duclos J, Dechelotte P, Hanachi M, Fetissov S, Godart N, Melchior JC, Ramoz N, Rovere-Jovene C, Tolle V, Viltart O, Epelbaum J. New Insights in Anorexia Nervosa. Front Neurosci. 2016 Jun 29;10:256. doi: 10.3389/fnins.2016.00256. eCollection 2016.
- Schoen SA, Miller LJ, Green KE. Pilot study of the Sensory Over-Responsivity Scales: assessment and inventory. Am J Occup Ther. 2008 Jul-Aug;62(4):393-406. doi: 10.5014/ajot.62.4.393.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP211140
- 2021-A01755-36 (OTHER: France : ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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