Trial Parameters
Brief Summary
Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use. Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.
Eligibility 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 wom