Evaluation of Safe Use of SECURIDRAP® SELFIA®

The proposed study is a prospective, multicenter, interventional and non-comparative research.

This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.

This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.

The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.

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