Eating Disorders in AdolescenceODYSSEDNCT05091983
Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality
An observational study of Eating Disorders in Adolescence and Avoidant Restrictive Food Intake Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Eating Disorders in Adolescence, Avoidant Restrictive Food Intake Disorder
- What is being tested?
- Sensory Processing Scale Inventory (SPSI), Autism Spectrum Screening Quotient (ASSQ) and GAD 7
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2021to 24 Mar 2022
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The participants were all recruited at the Maison de Solenn, Cochin - Paris, a service specialized in the treatment of eating disorders for adolescents. The participants in the control group are patients followed in this center for another reason than an eating disorder. The participants were recruited in consultation, in day hospital or in complete hospitalization.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Maison de Solenn Maison des Adolescents, Cochin Hospital
Paris, IDF, 75014
About this study
Official title: Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (Orality Dysensoriality and Eating Disorder)
This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.
Read the 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.
- Being tested
- Sensory Processing Scale Inventory (SPSI), Autism Spectrum Screening Quotient (ASSQ), GAD 7, Conners abridged, EAT 26
- Keywords
- Restrictive eating disorder, anorexia nervosa, Avoidant/Restrictive Food Intake Disorder, sensory modulation disorder, sensory modulation symptoms, sensory over responsivity, sensory integration
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Processing Scale Inventory (SPSI)Other
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
Autism Spectrum Screening Quotient (ASSQ)Other
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.
GAD 7Other
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.
Conners abridgedOther
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.
EAT 26Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive eating disorder group | Adolescents between 12 and 18 y.o. Restrictive eating disorders diagnosis (Anorexia Nervosa or ARFID) answering DSM-5 criteria Receives: Other: Sensory Processing Scale Inventory (SPSI); Other: Autism Spectrum Screening Quotient (ASSQ); Other: GAD 7; Other: Conners abridged; Other: EAT 26 | |
| Control group | Adolescents between 12 and 18 y.o. No eating disorders Receives: Other: Sensory Processing Scale Inventory (SPSI); Other: Autism Spectrum Screening Quotient (ASSQ); Other: GAD 7; Other: Conners abridged |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Sensory Processing Scale Inventory (SPSI) scores between the two groups
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).
Measured: Inclusion
Secondary outcomes (4)
Screening for pathologies known to be associated with a sensory disorder
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.
Measured: Inclusion
Screening for pathologies known to be associated with a sensory disorder
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.
Measured: Inclusion
Screening for pathologies known to be associated with a sensory disorder
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.
Measured: Inclusion
Search for a link between the eating disorders severity and sensory disorders
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.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start30 Nov 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eating Disorders in AdolescenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Corinne BLANCHET, Principal investigator, APHP - Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091983
- Sponsor's protocol ID
- APHP211140
- Other IDs
- 2021-A01755-36
- Acronym
- ODYSSED
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24413388Gorwood 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.
PubMed 27445651Schoen 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.
PubMed 18712002
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (Orality Dysensoriality and Eating Disorder)
- ClinicalTrials.gov ID
- NCT05091983
- Acronym / sponsor ID
- ODYSSED / APHP211140
- Keywords
- Restrictive eating disorder, anorexia nervosa, Avoidant/Restrictive Food Intake Disorder, sensory modulation disorder, sensory modulation symptoms, sensory over responsivity, sensory integration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 25 Oct 2021 (actual)
- 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.
This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive eating disorder group | – | Other: Sensory Processing Scale Inventory (SPSI), Other: Autism Spectrum Screening Quotient (ASSQ), Other: GAD 7, Other: Conners abridged, Other: EAT 26Adolescents between 12 and 18 y.o. Restrictive eating disorders diagnosis (Anorexia Nervosa or ARFID) answering DSM-5 criteria |
| Control group | – | Other: Sensory Processing Scale Inventory (SPSI), Other: Autism Spectrum Screening Quotient (ASSQ), Other: GAD 7, Other: Conners abridgedAdolescents between 12 and 18 y.o. No eating disorders |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The participants were all recruited at the Maison de Solenn, Cochin - Paris, a service specialized in the treatment of eating disorders for adolescents. The participants in the control group are patients followed in this center for another reason than an eating disorder. The participants were recruited in consultation, in day hospital or in complete hospitalization.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Sensory Processing Scale Inventory (SPSI)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 | Other | Control group, Restrictive eating disorder group |
| Autism Spectrum Screening Quotient (ASSQ)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. | Other | Control group, Restrictive eating disorder group |
| GAD 7The 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. | Other | Control group, Restrictive eating disorder group |
| Conners abridgedThe 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. | Other | Control group, Restrictive eating disorder group |
| EAT 26The 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. | Other | Restrictive eating disorder group |
Primary outcome
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).
4 secondary outcomes
Screening for pathologies known to be associated with a sensory disorder
Time frame: Inclusion
Screening for pathologies known to be associated with a sensory disorder
Time frame: Inclusion
Screening for pathologies known to be associated with a sensory disorder
Time frame: Inclusion
Search for a link between the eating disorders severity and sensory disorders
Time frame: Inclusion
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 12 Sep 2025.
- Background: PubMed 24413388Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
- Background: PubMed 27445651Gorwood 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.
- Background: PubMed 18712002Schoen 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.
- LEBLANC V, LECOUFLE A, BOURGEOIS C, al et. Boîte à idées pour oralité malmenée du jeune enfant \[Internet\]. Nutricia; s. d. 19 pLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Corinne BLANCHET principal investigator
APHP - Cochin Hospital
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 Eating Disorders in Adolescence and Avoidant Restrictive Food Intake Disorder, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 5 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 12 Sep 2025. 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.
What does the primary outcome measure?
Average Sensory Processing Scale Inventory (SPSI) scores between the two groups (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091983, which also lists 3 linked publications.
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 12 Sep 2025.