Autism Spectrum Disorder
Conditions
Keywords
autism, autism spectrum disorder, ASD, sleep, Circadian, Biological rhythms, melatonin, Cognition, Behavior, Longitudinal, Longitudinal accelerated design
Brief summary
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).
Interventions
OTHERpolysomnography
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep latency 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 | Sleep latency derived from actigraphy |
| Change in sleep fragmentation index 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 | Sleep fragmentation index derived from polysomnography (PSG) |
| Change in nocturnal melatonin secretion 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 | Nocturnal melatonin secretion (6-SMT measured in night urine from 8pm to 8am) |
| Change in amplitude of the day-night melatonin secretion 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 | Amplitude of the day-night melatonin secretion (6 sulfatoxy-melatonin (6-SMT) measured in 12h-night versus 12h-day urine) |
| 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 | 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 |
| Change in Raven performance IQ 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 | Raven performance IQ derived from Raven progressive matrices (CPM-BF) at 1 year follow-up and 2 year follow-up compared to baseline |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Level of ferritin in plasma | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up | — |
| Total sleep time (TST) | 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) | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up | Level of ferritin in plasma |
| Circadian phase of body temperature | Three annual assessments: baseline, 1 year follow-up, 2 year follow-up | — |
Countries
France
Contacts
Primary ContactCarmen SCHRODER, MD,PhD
Outcome results
None listed