Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?
- Conditions
- Autism Spectrum Disorder
- Interventions
- Other: polysomnography
- Registration Number
- NCT02878499
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASD polysomnography -
- Primary Outcome Measures
Name Time Method 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Sleep spindle density in light slow wave 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 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) 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 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 24h urinary 6-sulfatoxymelatonin levels (ng/ml) 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 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
Trial Locations
- Locations (5)
CHRU de Lille - Hôpital Roger Salengro
🇫🇷Lille, France
CHU Gui de Chaulhiac
🇫🇷Montpellier, France
CHU de TOURS - Hôpital Bretonneau
🇫🇷Tours, France
CHU de Lyon - CHS Le Vinatier
🇫🇷Lyon, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France