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Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

NCT ID: NCT01984944

Last Updated: 2014-11-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Autistic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Autistic Patient

* 50 adults
* 25 childs

Group Type OTHER

Autistic functional exploration

Intervention Type 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

Controls

* 50 adults
* 25 childs

Group Type OTHER

Control functional exploration

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henri Mondor University Hospital

OTHER

Sponsor Role collaborator

Albert Chenevier Hospital (Department of Psychiatry)

UNKNOWN

Sponsor Role collaborator

Hopital Universitaire Robert-Debre

OTHER

Sponsor Role collaborator

Pasteur Institute (Cognitive Function and Human Genetic)

UNKNOWN

Sponsor Role collaborator

Fondation FondaMental

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier DROUOT, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Henri Mondor Hospital

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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2009-011842-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P081103

Identifier Type: -

Identifier Source: org_study_id