Assessing the safety of SECURIDRAP® SELFIA® bedding
Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
This study is testing if a new type of bedding is safe for patients with disorientation and behavioral issues over a 15-night period.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Mulliez-Flory Industry-sponsored |
| Locations | 10 sites (Bailleul and 9 other locations) |
| Trial ID | NCT05510401 on ClinicalTrials.gov |
What this trial studies
This interventional clinical investigation evaluates the safety of the SECURIDRAP® SELFIA® bedding in patients experiencing disorientation, cognitive impairment, and behavioral disorders. Conducted across nine healthcare facilities in France, the study involves monitoring patients for 15 nights to ensure proper use of the bedding and to record any adverse events. The study is designed to confirm the safety of this second version of the bedding following the withdrawal of its first version from the market. Patients will be included based on specific eligibility criteria, and their experiences will be assessed by an independent evaluator.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have a medical prescription for SECURIDRAP® SELFIA® and are experiencing disorientation or nocturnal behavioral disorders.
Not a fit: Patients with severe agitation, those who can easily extract themselves from the bedding, or those without social coverage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and comfort of patients with cognitive impairments and behavioral disorders during sleep.
How similar studies have performed: While this study focuses on a specific product, similar approaches in assessing safety and efficacy of medical devices have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient at least 18 years old * Patient having a medical prescription for SÉCURIDRAP® SELFIA® * Patient in phase or state of disorientation * Patient with nocturnal behavior disordre * Patient with major cognitive impairment * Patient at risk of falling into bed * Patient subject to guardianship or curatorship * Patient beneficiary or affiliated to a social security scheme * Patient who has given their participation agreement aand informed consent Exclusion Criteria: * Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation * Patient in psychiatry * Patient with severe agitation * Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA® * Patient with intolerance to the medical device * Patient able to extract himself from SÉCURIDRAP® SELFIA® * Patient able to unlock the bed rails by himself * Patient without social coverage or not benefiting from it through a third party * Patient minor, pregnant woman, persons deprived of their liberty * Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion
Where this trial is running
Bailleul and 9 other locations
- CMMF de Bailleul — Bailleul, France (Recruiting)
- EHPAD l'Aquarelle — Bully-les-Mines, France (Recruiting)
- Centre Hospitalier d'Hazebrouck — Hazebrouck, France (Recruiting)
- Centre Hospitalier Le Quesnoy — Le Quesnoy, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- Ussap- Asm Limoux — Limoux, France (Recruiting)
- CHU Lyon — Lyon, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- CHG Roubaix — Roubaix, France (Recruiting)
- CSSR La Clauze — Saint-Jean-Delnous, France (Recruiting)
Study contacts
- Principal investigator: François Pr PUISIEUX — CHU Lille
- Study coordinator: Céline BETOUX
- Email: c.betoux@mulliez-flory.fr
- Phone: 0241637810
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.