NCT03915418 Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
| NCT ID | NCT03915418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Sleep Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2021-01-12 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2021-01-12 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Boy or girl between 6 and 15 years old * Confirmed diagnosis of cerebral palsy * GMFCS class\> 3 * Parents and child agreement Exclusion Criteria: * 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
Contact & Investigator
Juliette Ropars, MD
PRINCIPAL INVESTIGATOR
Brest University Hospital in France
Frequently Asked Questions
Who can join the NCT03915418 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 15 Years, studying Sleep Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03915418 currently recruiting?
Yes, NCT03915418 is actively recruiting participants. Contact the research team at juliette.ropars@chu-brest.fr for enrollment information.
Where is the NCT03915418 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Brest, France, Nantes, France and 2 additional locations.
Who is sponsoring the NCT03915418 clinical trial?
NCT03915418 is sponsored by University Hospital, Brest. The principal investigator is Juliette Ropars, MD at Brest University Hospital in France. The trial plans to enroll 140 participants.