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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASD | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysomnography | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep latency at 1 year follow-up and 2 year follow-up compared to baseline | 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 | 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 | 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 | 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 | 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 | 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 |
| 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…) | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up | |
| Total sleep time (TST) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen SCHRODER, MD,PhD | Contact | 3 88 11 62 18 | +33 | schroderc@unistra.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Lille - Hôpital Roger Salengro | Recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 | 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 | 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 | 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) | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up |
| Sleep spindle density in light slow wave sleep | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up |
| Density of rapid eye movements in REM sleep | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up |
| Spectral analysis of the sleep electro-encephalogram (EEG) | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up |
| 24h urinary 6-sulfatoxymelatonin levels (ng/ml) | 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) | Level of ferritin in plasma | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up |
| Circadian phase of body temperature | 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 |
| CHU de Lyon - CHS Le Vinatier | Recruiting | Lyon | 69100 | France |
|
| CHU Gui de Chaulhiac | Recruiting | Montpellier | 34295 | France |
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| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67091 | France |
|
| CHU de TOURS - Hôpital Bretonneau | Recruiting | Tours | 37044 | France |
|