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Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Autistic functional exploration
Control functional exploration
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autistic Disorder focused on measuring circadian rhythm

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Autistic Patient

Controls

Arm Description

50 adults 25 childs

50 adults 25 childs

Outcomes

Primary Outcome Measures

Urinary sulfatoxymelatonin secretion
Urinary sulfatoxymelatonin secretion

Secondary Outcome Measures

Core body temperature rhythm
Circadian rhythms assessed with actometer

Full Information

First Posted
October 29, 2013
Last Updated
November 6, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Henri Mondor University Hospital, Albert Chenevier Hospital (Department of Psychiatry), Hopital Universitaire Robert-Debre, Pasteur Institute (Cognitive Function and Human Genetic), Fondation FondaMental
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1. Study Identification

Unique Protocol Identification Number
NCT01984944
Brief Title
Characterisation of Circadian Rhythm in Autistic Spectrum Disorder
Official Title
Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Henri Mondor University Hospital, Albert Chenevier Hospital (Department of Psychiatry), Hopital Universitaire Robert-Debre, Pasteur Institute (Cognitive Function and Human Genetic), Fondation FondaMental

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
circadian rhythm

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autistic Patient
Arm Type
Other
Arm Description
50 adults 25 childs
Arm Title
Controls
Arm Type
Other
Arm Description
50 adults 25 childs
Intervention Type
Other
Intervention Name(s)
Autistic functional exploration
Intervention Description
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
Intervention Name(s)
Control functional exploration
Intervention Description
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 Outcome Measure Information:
Title
Urinary sulfatoxymelatonin secretion
Time Frame
The determination will be performed at 14 days ( child)
Title
Urinary sulfatoxymelatonin secretion
Time Frame
The determination will be performed at 21 days ( adults)
Secondary Outcome Measure Information:
Title
Core body temperature rhythm
Time Frame
The determination will be performed at 5 days (adult)
Title
Circadian rhythms assessed with actometer
Time Frame
The determination will be performed at 14 ( child) and 21 days (adult)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DROUOT, MCU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

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