Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

Not Applicable

Completed

• Conditions: Autistic Disorder
• Interventions: Other: Autistic functional exploration; Other: Control functional exploration

• Registration Number: NCT01984944
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-15
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autistic Patient	Autistic functional exploration	* 50 adults * 25 childs
Controls	Control functional exploration	* 50 adults * 25 childs

Primary Outcome Measures

Name	Time	Method
Urinary sulfatoxymelatonin secretion	The determination will be performed at 21 days ( adults)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France