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Completed

NCT Number: NCT01984944

Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

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.

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autistic functional exploration

Other
  • 50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer
  • 25 childs with urinary sample, Circadian rhythms assessed with actometer

Control functional exploration

Other
  • 50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer
  • 25 childs with urinary sample, Circadian rhythms assessed with actometer

Primary outcomes

  1. Urinary sulfatoxymelatonin secretion

    Time frame: The determination will be performed at 14 days ( child)

  2. Urinary sulfatoxymelatonin secretion

    Time frame: The determination will be performed at 21 days ( adults)

Secondary outcomes

  1. Core body temperature rhythm

    Time frame: The determination will be performed at 5 days (adult)

  2. Circadian rhythms assessed with actometer

    Time frame: The determination will be performed at 14 ( child) and 21 days (adult)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Albert Chenevier Hospital (Department of Psychiatry)
  • Fondation FondaMental
  • Henri Mondor University Hospital
  • Hopital Universitaire Robert-Debre
  • Pasteur Institute (Cognitive Function and Human Genetic)

Registry information

Official study title

Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2013
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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