Screening for sleep disorders in children with cerebral palsy using connected tools
Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
This study is testing a new way to use connected tools to find sleep problems in children with cerebral palsy, so they can get the help they need.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 6 sites (Angers and 5 other locations) |
| Trial ID | NCT03915418 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a method for screening sleep disorders in children with cerebral palsy (CP) using connected technologies. Given that nearly 40% of children with CP experience sleep disorders that often go undiagnosed, the study seeks to optimize the screening process to identify those who may require further evaluation through polysomnography (PSG). By leveraging connected tools, the research intends to improve access to diagnosis and management of sleep disorders in this population. The study will involve children aged 6 to 15 years with confirmed CP and will assess the effectiveness of these technologies in selecting candidates for PSG.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 15 years with a confirmed diagnosis of cerebral palsy and a Gross Motor Function Classification System (GMFCS) class greater than 3.
Not a fit: Patients who are currently receiving pharmacological treatment for sleep disorders or those requiring ventilatory support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of sleep disorders in children with cerebral palsy, enhancing their overall quality of life.
How similar studies have performed: While the use of connected tools for screening is an innovative approach, similar studies have shown promise in improving diagnosis and management of sleep disorders in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 5 other locations
- CHU Angers — Angers, France (Not_yet_recruiting)
- CHRU Brest — Brest, France (Recruiting)
- Fondation Ildys Ty-Yann — Brest, France (Not_yet_recruiting)
- ESEAN Nantes — Nantes, France (Not_yet_recruiting)
- AP-HP Hôpital Trousseau — Paris, France (Not_yet_recruiting)
- Kerpape — Ploemeur, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Juliette Ropars, MD — Brest University Hospital in France
- Study coordinator: Juliette Ropars, MD
- Email: juliette.ropars@chu-brest.fr
- Phone: 02 98 22 33 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.