Sleep DisordersSOUTIEN-PCNCT03915418
Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
A study testing Connected tools in people with Sleep Disorders, run by University Hospital, Brest at 6 sites in France.
Trial summary
Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Connected tools
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesFrance
- Study dates
- 12 Jan 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boy or girl between 6 and 15 years old
- Confirmed diagnosis of cerebral palsy
- GMFCS class> 3
- Parents and child agreement
Who cannot join
- Pharmacological treatment of sleep disorders
- Diurnal and / or nocturnal ventilatory support
- Difficulty understanding and / or participation
- Subjects under 6 and over 15
- Refusal to participate
- Not affiliated with and not a beneficiary of a health insurance plan
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
CHU Angers
Angers, 49000
Mickael Dinomais, Professor, mickael.dinomais@gmail.com
- Recruiting
CHRU Brest
Brest, 29200
Juliette Ropars, MD, juliette.ropars@chu-brest.fr
- Not yet recruiting
Fondation Ildys Ty-Yann
Brest, 29218
Audrey Barzic, MD, audrey.bazic@ildys.org
- Not yet recruiting
ESEAN Nantes
Nantes, 44200
Guy Letellier, MD
- Not yet recruiting
AP-HP Hôpital Trousseau
Paris, 75012
Guillaume Aubertin, MD, guillaume.aubertin@aphp.fr
- Not yet recruiting
Kerpape
Ploemeur, 56275
Véronique Bernier-François, MD, vbernier-francois@kerpape.mutualite56.fr
About this study
Official title: Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.
- Conditions
- Sleep Disorders
- Being tested
- Connected tools
- Keywords
- Screening, sleep disorders, children, cerebral palsy, connected tools
- Medical subject headings
- Sleep Wake Disorders, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected toolsProcedure or surgery
At home, parents will record their child's sleep for 1night Then, on the date scheduled for the inclusion of the children and after the recording of the 1 night at home, the child will spend a night in a hospital environment to carry out the recording by polysomnography and tools connected simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Connected tools | Experimental | 1 night at home with connected tools only and 1 night at hospital with connected tools and PSG. Receives: Procedure: Connected tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the diagnosis of sleep disorder
Sensitivity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Measured: 15 days
Specificity of the diagnosis of sleep disorder
Specificity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Measured: 15 days
Secondary outcomes (5)
Diagnosis
Sensitivity and specificity of sleep disorder diagnosis using tools connected during 1 night at home (in comparaison with sleep disorder diagnosis using PSG)
Measured: 15 days
Acceptability assessed by acceptability score for parents, and if possible children
Acceptability assessed by the acceptability score for parents, and if possible children, obtained by the SUS "System Usability Scale" scale. This questionnaire consists of ten questions to collect the subjective point of view of the user on the systems used
Measured: 15 days
Sleep Quality Questionnaire
Sleep quality questionnaire used as a screening tool for sleep disorders: use of the Sleep Disturbance Scale for Children. Sleep Disturbance Scale for Children (SDSC) is a screening tool for sleep disorders in children and adolescents with good psychometric properties. It is one of the most used sleep questionnaires in the clinic but also in clinical research. Since its creation, the SDSC has been translated into several languages and recently validated in French. The ranking is obtained from a 26-item questionnaire completed by the parents. This scale distinguishes 6 major groups of sleep disorders: disorders of the installation or maintenance of sleep, breathing disorders, waking disorders, sleep-wake transition disorders, excessive daytime sleepiness and hypersudation of sleep.
Measured: 15 days
Data quality outcome measures
Data quality will be assessed by establishing for each sensor the ratio (expressed in percent value) between the duration of the data effectively recorded to the total duration the patient weared the sensors. Pauses in recording during recording sessions will be identified in absolute value and duration for each sensor. Specific issues in recording will be reported, especially regarding the contents of RAW files.
Measured: 25 months
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life, measured as quality-adjusted life year QALY, will be simulated for one-year health conditions.
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start12 Jan 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Ropars, MD, Principal investigator, Brest University Hospital in France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915418
- Sponsor's protocol ID
- SOUTIEN-PC (29BRC18.0178)
- Acronym
- SOUTIEN-PC
- Status last verified
- Jun 2026
- First submitted
- 7 Dec 2018
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
- ClinicalTrials.gov ID
- NCT03915418
- Acronym / sponsor ID
- SOUTIEN-PC / SOUTIEN-PC (29BRC18.0178)
- Conditions
- Sleep Disorders
- Keywords
- Screening, sleep disorders, children, cerebral palsy, connected tools
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Apr 2019 (actual)
- 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.
Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Connected tools | Experimental | Procedure: Connected tools1 night at home with connected tools only and 1 night at hospital with connected tools and PSG. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Boy or girl between 6 and 15 years old
- Confirmed diagnosis of cerebral palsy
- GMFCS class> 3
- Parents and child agreement
Key exclusion criteria (6 listed)
- Pharmacological treatment of sleep disorders
- Diurnal and / or nocturnal ventilatory support
- Difficulty understanding and / or participation
- Subjects under 6 and over 15
- Refusal to participate
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 |
|---|---|---|
| Connected toolsAt home, parents will record their child's sleep for 1night Then, on the date scheduled for the inclusion of the children and after the recording of the 1 night at home, the child will spend a night in a hospital environment to carry out the recording by polysomnography and tools connected simultaneously. | Procedure or surgery | Connected tools |
Primary outcome
Sensitivity of the diagnosis of sleep disorder
Time frame: 15 days
Sensitivity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Specificity of the diagnosis of sleep disorder
Time frame: 15 days
Specificity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
5 secondary outcomes
Diagnosis
Time frame: 15 days
Acceptability assessed by acceptability score for parents, and if possible children
Time frame: 15 days
Sleep Quality Questionnaire
Time frame: 15 days
Data quality outcome measures
Time frame: 25 months
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life
Time frame: 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
Juliette Ropars, MD principal investigator
Brest University Hospital in France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected tools in people with Sleep Disorders, run by University Hospital, Brest at 6 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliette Ropars, MD (02 98 22 33 89 ext. +33, juliette.ropars@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the diagnosis of sleep disorder (time frame: 15 days). The study lists 2 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 25 Jun 2026.