Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

November 6, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary sulfatoxymelatonin secretion
Time Frame: The determination will be performed at 14 days ( child)
The determination will be performed at 14 days ( child)
Urinary sulfatoxymelatonin secretion
Time Frame: The determination will be performed at 21 days ( adults)
The determination will be performed at 21 days ( adults)

Secondary Outcome Measures

Outcome Measure
Time Frame
Core body temperature rhythm
Time Frame: The determination will be performed at 5 days (adult)
The determination will be performed at 5 days (adult)
Circadian rhythms assessed with actometer
Time Frame: The determination will be performed at 14 ( child) and 21 days (adult)
The determination will be performed at 14 ( child) and 21 days (adult)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (ESTIMATE)

November 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P081103
  • 2009-011842-24 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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