Characterisation of Circadian Rhythm in Autistic Spectrum Disorder
2 other identifiers
interventional
42
1 country
1
Brief Summary
Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by deficits in social communication, delay in language and repetitive behaviors. Results from genetic studies reveal one pathway associated with susceptibility to ASDs, which includes synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with ASD and search for circadian rhythms genes polymorphisms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedNovember 7, 2014
November 1, 2014
3.8 years
October 29, 2013
November 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Urinary sulfatoxymelatonin secretion
The determination will be performed at 14 days ( child)
Urinary sulfatoxymelatonin secretion
The determination will be performed at 21 days ( adults)
Secondary Outcomes (2)
Core body temperature rhythm
The determination will be performed at 5 days (adult)
Circadian rhythms assessed with actometer
The determination will be performed at 14 ( child) and 21 days (adult)
Study Arms (2)
Autistic Patient
OTHER* 50 adults * 25 childs
Controls
OTHER* 50 adults * 25 childs
Interventions
* 50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer * 25 childs with urinary sample, Circadian rhythms assessed with actometer
* 50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer * 25 childs with urinary sample, Circadian rhythms assessed with actometer
Eligibility Criteria
You may qualify if:
- Patients with autistic spectrum disorders
- At least 6 years old
- Membership of a social security scheme
- Informed consent signed by the patient or both holders of parental authority if the subject is a minor, or by a guardian if the subject is under guardianship
You may not qualify if:
- Recent sleep symptoms
- Incapacity to keep rested for 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Henri Mondor University Hospitalcollaborator
- Albert Chenevier Hospital (Department of Psychiatry)collaborator
- Hopital Universitaire Robert-Debrecollaborator
- Pasteur Institute (Cognitive Function and Human Genetic)collaborator
- Fondation FondaMentalcollaborator
Study Sites (1)
Henri Mondor Hospital
Créteil, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier DROUOT, MCU-PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 15, 2013
Study Start
October 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
November 7, 2014
Record last verified: 2014-11