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Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01984944
Collaborator
Henri Mondor University Hospital (Other), Albert Chenevier Hospital (Department of Psychiatry) (Other), Robert Debré Hospital (Other), Pasteur Institute (Cognitive Function and Human Genetic) (Other), Fondation FondaMental (Other)
42
Enrollment
1
Location
2
Arms
46
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Autistic functional exploration
  • Other: Control functional exploration
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Autistic Patient

50 adults 25 childs

Other: Autistic functional exploration
50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer 25 childs with urinary sample, Circadian rhythms assessed with actometer
Other: Controls

50 adults 25 childs

Other: Control functional exploration
50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer 25 childs with urinary sample, Circadian rhythms assessed with actometer

Outcome Measures

Primary Outcome Measures

  1. Urinary sulfatoxymelatonin secretion [The determination will be performed at 14 days ( child)]

  2. Urinary sulfatoxymelatonin secretion [The determination will be performed at 21 days ( adults)]

Secondary Outcome Measures

  1. Core body temperature rhythm [The determination will be performed at 5 days (adult)]

  2. Circadian rhythms assessed with actometer [The determination will be performed at 14 ( child) and 21 days (adult)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Recent sleep symptoms

  • Incapacity to keep rested for 24 hours

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henri Mondor Hospital Creteil France 94000

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Henri Mondor University Hospital
  • Albert Chenevier Hospital (Department of Psychiatry)
  • Robert Debré Hospital
  • Pasteur Institute (Cognitive Function and Human Genetic)
  • Fondation FondaMental

Investigators

  • Principal Investigator: Xavier DROUOT, MCU-PH, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01984944
Other Study ID Numbers:
  • P081103
  • 2009-011842-24
First Posted:
Nov 15, 2013
Last Update Posted:
Nov 7, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris
circadian rhythm
Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder

Study Results

No Results Posted as of Nov 7, 2014