Autonomic Nervous System DiseasesAPAUTRESNCT02830022
Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES)
A study testing physiological explorations in people with Autonomic Nervous System Diseases and Sleep, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Diseases, Sleep
- What is being tested?
- physiological explorations
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2013to 18 Jun 2017
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children physically active
- children with an intellectual quotient >70
- for autism children a diagnosis of autism in accordance to DSMV
Who cannot join
- history of cardio-vascular disease
- history of asthma or respiratory disease
- Behavior disorders.
- medical treatment by neuroleptic or melatonin or antiepileptic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children
Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system).
An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.
- Conditions
- Autonomic Nervous System Diseases, Sleep
- Being tested
- physiological explorations
- Keywords
- autism spectrum disorder
- Medical subject headings
- Autonomic Nervous System Diseases, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiological explorationsOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Children from 8 to 18 years with autism without without intellectual disabilities (IQ > 70), verbals and responding to classification CIM 10-DSM IV. Receives: Other: physiological explorations |
| Healthy volunteers | Experimental | Paired for age, gender, IQ and and the practice of a physical activity strictly within the school context. Receives: Other: physiological explorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiorespiratory evaluation
a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)
Measured: 1 day
autonomic nervous system evaluation
an orthostatic test is proposed in order to verify the ANS adaptation. A nocturnal recording is made during three nights in order to verify the possible link between the rest autonomic adaptations and a possible dysautonomia observed with the orthostatic test.
Measured: 1 day and 3 nights
sleep evaluation
Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders.
Sleep Questionnaires are also completed.
Measured: 7 nights
Secondary outcomes (4)
physical activity
physical activity characteristics (sedentary, moderate or vigorous activities, energy expenditure) are obtained by an actimetry during 7 days.
Questionnaires of physical activity are also completed
Measured: 7 days
Motor capacities
motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.
Measured: 1 day
Behavioural characteristics
Behavioural characteristics are evaluated by the Vineland scale
Measured: 1 hour
biological parameters
during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start11 Dec 2013
- Primary completion11 Jun 2017
- Study completion18 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique BRICOUT, PhD, Principal investigator, CHU Grenoble FranceMichel GUINOT, Dr, Principal investigator, CHU Grenoble France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830022
- Sponsor's protocol ID
- 38RC14.123
- Acronym
- APAUTRES
- Status last verified
- Oct 2018
- First submitted
- 7 Jul 2016
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children
- ClinicalTrials.gov ID
- NCT02830022
- Acronym / sponsor ID
- APAUTRES / 38RC14.123
- Conditions
- Autonomic Nervous System Diseases, Sleep
- Keywords
- autism spectrum disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 11 Dec 2013 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 18 Jun 2017 (actual)
- First posted
- 12 Jul 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.
Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system).
An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: physiological explorationsChildren from 8 to 18 years with autism without without intellectual disabilities (IQ > 70), verbals and responding to classification CIM 10-DSM IV. |
| Healthy volunteers | Experimental | Other: physiological explorationsPaired for age, gender, IQ and and the practice of a physical activity strictly within the school context. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children physically active
- children with an intellectual quotient >70
- for autism children a diagnosis of autism in accordance to DSMV
Key exclusion criteria (4 listed)
- history of cardio-vascular disease
- history of asthma or respiratory disease
- Behavior disorders.
- medical treatment by neuroleptic or melatonin or antiepileptic
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 |
|---|---|---|
| physiological explorations | Other | Healthy volunteers, Patients |
Primary outcome
cardiorespiratory evaluation
Time frame: 1 day
a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)
autonomic nervous system evaluation
Time frame: 1 day and 3 nights
an orthostatic test is proposed in order to verify the ANS adaptation. A nocturnal recording is made during three nights in order to verify the possible link between the rest autonomic adaptations and a possible dysautonomia observed with the orthostatic test.
sleep evaluation
Time frame: 7 nights
Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders. Sleep Questionnaires are also completed.
4 secondary outcomes
physical activity
Time frame: 7 days
Motor capacities
Time frame: 1 day
Behavioural characteristics
Time frame: 1 hour
biological parameters
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Véronique BRICOUT, PhD principal investigator
CHU Grenoble France
Michel GUINOT, Dr principal investigator
CHU Grenoble France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiological explorations in people with Autonomic Nervous System Diseases and Sleep, run by University Hospital, Grenoble at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiorespiratory evaluation (time frame: 1 day). The study lists 3 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 Oct 2018.