Autistic DisorderDo Well BNCT02275455
Design Of WELL Being Monitoring Systems, Application in Autism
A study testing real life situations in people with Autistic Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- real life situations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Dec 2018
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clear autism spectrum disorder, based on the autism diagnostic interview - revised (ADI-R), the autism diagnostic observation schedule - generic (ADOS-G), and the Vineland adaptive behavior scales (VABS).
Who cannot join
- change in medical prescription in the previous 3 months and during the experiment.
- The same inclusion criteria will apply for the paired age and sex matched individuals with the exception of autism spectrum. The paired control will be chosen within the friends of individuals with autism. In case of difficulty to recruit controls, the psychologist referent may be served as control.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Clermont-Ferrand (CHU), France
Clermont-Ferrand, France, 63000
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
The worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.
Read the detailed description
The protocol will take place in real life (home and social environments). We aim to associate modifications of ANS with external events which will all be recorded in a synchrony manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. We will apply the statistical analyses developed by our team on continuous ANS data. Detection of abrupt changes will allow segmenting the data in shorter time series of few minutes with a constant mean, and estimating their persistency or antipersistency through a piecewise constant fractal index. We will disentangle classes characterizing different behaviors such as anxiety, rest and physical activity.
- Conditions
- Autistic Disorder
- Being tested
- real life situations
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real life situationsBehavioural
Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events.
| Study group | Role | What they receive |
|---|---|---|
| Participants with autism | Experimental | Not described Receives: Behavioral: real life situations |
| Aged-matched controls | Experimental | Not described Receives: Behavioral: real life situations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability from holter electrocardiogram
Measured: at day 1
Secondary outcomes (1)
Heart Rate Variability from the heart rate transmitter belt
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Dutheil, MD PhD, Principal investigator, University Hospital of Clermont-Ferrand (CHU), France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275455
- Sponsor's protocol ID
- CHU-0213
- Other IDs
- 2014-A00611-46
- Acronym
- Do Well B
- Status last verified
- Jul 2016
- First submitted
- 14 Oct 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dutheil F, Chambres P, Hufnagel C, Auxiette C, Chausse P, Ghozi R, Paugam G, Boudet G, Khalfa N, Naughton G, Chamoux A, Mermillod M, Bertrand PR. 'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism. BMJ Open. 2015 Feb 20;5(2):e007716. doi: 10.1136/bmjopen-2015-007716.
PubMed 25710916
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design Of WELL Being Monitoring Systems, Application in Autism
- ClinicalTrials.gov ID
- NCT02275455
- Acronym / sponsor ID
- Do Well B / CHU-0213
- Conditions
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Oct 2014 (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 worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.
Detailed description
The protocol will take place in real life (home and social environments). We aim to associate modifications of ANS with external events which will all be recorded in a synchrony manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. We will apply the statistical analyses developed by our team on continuous ANS data. Detection of abrupt changes will allow segmenting the data in shorter time series of few minutes with a constant mean, and estimating their persistency or antipersistency through a piecewise constant fractal index. We will disentangle classes characterizing different behaviors such as anxiety, rest and physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with autism | Experimental | Behavioral: real life situations |
| Aged-matched controls | Experimental | Behavioral: real life situations |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clear autism spectrum disorder, based on the autism diagnostic interview - revised (ADI-R), the autism diagnostic observation schedule - generic (ADOS-G), and the Vineland adaptive behavior scales (VABS).
Key exclusion criteria (2 listed)
- change in medical prescription in the previous 3 months and during the experiment.
- The same inclusion criteria will apply for the paired age and sex matched individuals with the exception of autism spectrum. The paired control will be chosen within the friends of individuals with autism. In case of difficulty to recruit controls, the psychologist referent may be served as control.
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 |
|---|---|---|
| real life situationsFour phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. | Behavioural | Aged-matched controls, Participants with autism |
Primary outcome
Heart Rate Variability from holter electrocardiogram
Time frame: at day 1
1 secondary outcome
Heart Rate Variability from the heart rate transmitter belt
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Derived from this study: PubMed 25710916Dutheil F, Chambres P, Hufnagel C, Auxiette C, Chausse P, Ghozi R, Paugam G, Boudet G, Khalfa N, Naughton G, Chamoux A, Mermillod M, Bertrand PR. 'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism. BMJ Open. 2015 Feb 20;5(2):e007716. doi: 10.1136/bmjopen-2015-007716.
- Related InfoLink provided by the sponsor.
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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.
Frédéric Dutheil, MD PhD principal investigator
University Hospital of Clermont-Ferrand (CHU), 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 real life situations in people with Autistic Disorder, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 2 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 26 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability from holter electrocardiogram (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02275455, which also lists 1 linked publication.
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 26 Jul 2016.