Autism Spectrum DisorderNCT02878499
Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?
A study testing polysomnography in people with Autism Spectrum Disorder, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 5 sitesFrance
- Study dates
- 19 Dec 2012to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHRU de Lille - Hôpital Roger Salengro
Lille, 59037
Jean-Louis GOEB, MD, 03 20 44 49 13 ext. +33, jl-goeb@chru-lille.fr
Jean-Louis GOEB, MD
- Recruiting
CHU de Lyon - CHS Le Vinatier
Lyon, 69100
Nicolas GEORGIEFF, 04 37 91 12 47 ext. +33, nicolas.georgieff@ch-le-vinatier.fr
Patricia FRANCO, 04 27 85 60 52 ext. +33, patricia.franco-gillioen@univ-lyon1.fr
- Recruiting
CHU Gui de Chaulhiac
Montpellier, 34295
Amaria BAGHDADLI, 04 67 33 99 68 ext. +33, cent-ress-autisme@chu-montpellier.fr
Amaria BAGHDADLI
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Carmen Schröder, MD, PhD, 3 88 11 62 18 ext. +33, schroderc@unistra.fr
Carmen SCHRÖDER
- Recruiting
CHU de TOURS - Hôpital Bretonneau
Tours, 37044
Frédérique BONNET-BRILHAULT, 02 47 47 84 12 ext. +33, f.bonnet-brilhault@chu-tours.fr
Nadège LIMOUSIN CHAMPFAILLY, 02 47 47 38 25 ext. +33, N.LIMOUSIN-CHAMPFAILLY@chu-tours.fr
About this study
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.
Read more
The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,
- sleep disturbances are correlated with circadian rhythm disturbances;
- both sleep and circadian rhythm disturbances are negatively correlated with cognitive performance and positively correlated with behavioural disturbances;
- 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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- polysomnography
- Keywords
- autism, autism spectrum disorder, ASD, sleep, Circadian, Biological rhythms, melatonin, Cognition, Behavior, Longitudinal, Longitudinal accelerated design
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyOther
| Study group | Role | What they receive |
|---|---|---|
| ASD | Other | Not described Receives: Other: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep latency at 1 year follow-up and 2 year follow-up compared to baseline
Sleep latency derived from actigraphy
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Secondary outcomes (10)
presence of an intrinsic sleep disorders (e.g. obstructive or central sleep apnea syndrome, restless legs syndrome and periodic limb movements during sleep…)
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Total sleep time (TST)
Measured: 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)
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Sleep spindle density in light slow wave sleep
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Density of rapid eye movements in REM sleep
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Spectral analysis of the sleep electro-encephalogram (EEG)
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
24h urinary 6-sulfatoxymelatonin levels (ng/ml)
Measured: 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
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Circadian phase of body temperature
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Level of ferritin in plasma
Measured: Three annual assessments: baseline, 1 year follow-up, 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start19 Dec 2012
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878499
- Sponsor's protocol ID
- 5060
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2016
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?
- ClinicalTrials.gov ID
- NCT02878499
- Acronym / sponsor ID
- 5060
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, autism spectrum disorder, ASD, sleep, Circadian, Biological rhythms, melatonin, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Dec 2012 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
- sleep disturbances are correlated with circadian rhythm disturbances;
- both sleep and circadian rhythm disturbances are negatively correlated with cognitive performance and positively correlated with behavioural disturbances;
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD | Other | Other: polysomnography |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnography | Other | ASD |
Primary outcome
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
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)
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)
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)
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
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
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
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
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
10 secondary outcomes
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
Total sleep time (TST)
Time frame: 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
Sleep spindle density in light slow wave sleep
Time frame: 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
Spectral analysis of the sleep electro-encephalogram (EEG)
Time frame: 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
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
Circadian phase of body temperature
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnography in people with Autism Spectrum Disorder, run by University Hospital, Strasbourg, France at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen SCHRODER, MD,PhD (3 88 11 62 18 ext. +33, schroderc@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.