Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-06-23
2025-12-31
Brief Summary
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Detailed Description
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This study is part of a wider project in collaboration with the team of S. Steculorum at the Max Planck Institute in Germany who assess the architectural and molecular characterization of the olfactory system development in a mice model of PWS and the role of early OT treatment.
Moreover, the study will take advantage of the MRI to document the long-term brain connectivity of early OT-exposed and non-exposed children.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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OT exposed patients
children OT exposed have olfactory test and fMRI
olfactory stimulation
the patients have a sniff-test
functional MRI
patients have a an f MRI
OT non exposed patients
children non- OT exposed have olfactory test and fMRI
olfactory stimulation
the patients have a sniff-test
functional MRI
patients have a an f MRI
Interventions
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olfactory stimulation
the patients have a sniff-test
functional MRI
patients have a an f MRI
Eligibility Criteria
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Inclusion Criteria
* Child aged between 5 and 7 years
* Child with a planned hospitalization at the Toulouse reference center for PWS
Exclusion Criteria
* Allergy to any of the fragrances used in the olfactory test
* Presence of an ENT infection such as rhinitis or sinusitis on the day of inclusion
* Reported anosmia
* Administrative problems.
5 Years
7 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Gwenaelle DIENE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Locations
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University Hospital
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Gwenaelle DIENE, MD
Role: primary
Other Identifiers
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RC31/23/0653
Identifier Type: -
Identifier Source: org_study_id
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