Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?

June 28, 2022 updated by: University Hospital, Strasbourg, France

The primary objective of this study is to undertake a longitudinal investigation of the impact of sleep and circadian rhythm disturbances on cognitive and behavioural trajectories in children with autism spectrum disorder (ASD) age 3-10 years old.

This innovative study will use objective quantifiable measures of sleep and circadian rhythms in addition to subjective measures.

The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,

  1. sleep disturbances are correlated with circadian rhythm disturbances;
  2. both sleep and circadian rhythm disturbances are negatively correlated with cognitive performance and positively correlated with behavioural disturbances;
  3. sleep and circadian rhythm disturbances, most notably abnormal melatonin secretion, impact the cognitive and behavioural development of children with ASD, depending on age (prospective longitudinal analyses).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

105

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 Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • CHRU de Lille - Hôpital Roger Salengro
        • Contact:
        • Principal Investigator:
          • Jean-Louis GOEB, MD
        • Sub-Investigator:
          • Christelle MONACA
      • Lyon, France, 69100
      • Montpellier, France, 34295
        • Recruiting
        • CHU Gui de Chaulhiac
        • Contact:
        • Principal Investigator:
          • Amaria BAGHDADLI
        • Sub-Investigator:
          • Yves DAUVILLIERS
      • Strasbourg, France, 67091
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Carmen SCHRÖDER
        • Sub-Investigator:
          • Patrice BOURGIN
      • Tours, France, 37044
        • Recruiting
        • CHU de TOURS - Hôpital Bretonneau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frédérique BONNET-BRILHAULT
        • Principal Investigator:
          • Nadège LIMOUSIN CHAMPFAILLY
        • Sub-Investigator:
          • Bertrand De TOFFOL

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

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age: from 3 to 8 years of age at inclusion, as per defined entry ages (longitudinal accelerated design)
  • Diagnostic criteria of autism spectrum disorder (ASD)
  • Autism Diagnostic Interview (ADI) - revised (R) score compatible with ASD diagnosis
  • Autism Diagnostic Observation Schedule (ADOS) score compatible with ASD diagnosis
  • Study information has been understood
  • Study consent signed by both parents or legal representatives and by the child if the child is capable of expressing his consent
  • Stable medication over the 2 months-period preceding inclusion and during evaluation periods (exception: (1) medication mentioned in the exclusion criteria, (2) a new medication instaurated between two evaluation periods is not in itself an exclusion criteria, but will be taken into account in data analysis)
  • Compliance with study procedures
  • Priori clinical medical examination
  • Child affiliated with social security Concerning sleep disorders: the discovery of a primary sleep disorder (e.g.: sleep apnea syndrome, restless legs syndrome, periodic limb movements during sleep) as well as their treatment is not a criteria for terminating the study but will be taken into account in data analysis

Exclusion criteria:

  • Secondary autism: e.g. associated with Rett syndrome, fragile X syndrome, Down syndrome, Bourneville tuberous sclerosis, von Recklinghausen disorder, Cytomegalovirus (CMV) encephalitis, congenital rubeola, phenylketonuria.
  • Current treatment with melatonin or melatonin agonists before study entry (before baseline assessment)
  • Changes in medication over the 2 months-period preceding the study (exception: a new medication instaurated between two evaluation periods is not in itself an exclusion criteria, but will be taken into account in data analysis)
  • Transmeridian travel (> 2 time zones) in the month preceding the study
  • Participation in other research studies in the 3 months period preceding the study
  • Treatment with betablockers, local or systemic non-steroidal anti-inflammatory (NSAI) agents, benzodiazepines, antidepressants
  • Severe other intercurrent disorder.
  • Severe allergies.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ASD
Other: polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep latency at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Sleep latency derived from actigraphy
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in sleep fragmentation index at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Sleep fragmentation index derived from polysomnography (PSG)
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in nocturnal melatonin secretion at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Nocturnal melatonin secretion (6-SMT measured in night urine from 8pm to 8am)
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in amplitude of the day-night melatonin secretion at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Amplitude of the day-night melatonin secretion (6 sulfatoxy-melatonin (6-SMT) measured in 12h-night versus 12h-day urine)
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in non-verbal index (INV, derived from the Kaufmann-Assessment Battery fir Children II (K-ABC II)) at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in verbal intelligence quotient (IQ) at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in verbal intelligence quotient (IQ) derived from the appropriate Wechsler scales for children (WPPSI or WISC) at 1 year follow-up and 2 year follow-up compared to baseline
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in Raven performance IQ at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Raven performance IQ derived from Raven progressive matrices (CPM-BF) at 1 year follow-up and 2 year follow-up compared to baseline
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in Autism Diagnostic Observation Schedule (ADOS), module 1-3: part 'D' et 'E' (repetitive and abnormal behaviour) at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Change in aberrant Behaviour Checklist (ABCL) global score at 1 year follow-up and 2 year follow-up compared to baseline
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of an intrinsic sleep disorders (e.g. obstructive or central sleep apnea syndrome, restless legs syndrome and periodic limb movements during sleep…)
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Total sleep time (TST)
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Time and percentage of TST spent in different sleep stages (slow wave sleep, rapid eye movement (REM) sleep)
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Sleep spindle density in light slow wave sleep
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Density of rapid eye movements in REM sleep
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Spectral analysis of the sleep electro-encephalogram (EEG)
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
24h urinary 6-sulfatoxymelatonin levels (ng/ml)
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Inter-daily stability (IS) and intra-daily variability (IV) of circadian rhythms (actigraphy derived)
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Level of ferritin in plasma
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Circadian phase of body temperature
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Level of ferritin in plasma
Time Frame: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Three annual assessments: baseline, 1 year follow-up, 2 year follow-up

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Actual)

December 19, 2012

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5060

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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