Assessing the safety of SECURIDRAP® SELFIA® bedding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: François Pr PUISIEUX — CHU Lille
• Study coordinator: Céline BETOUX
• Email: c.betoux@mulliez-flory.fr
• Phone: 0241637810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.