Limoux

Researchers are conducting a multicenter, prospective, interventional clinical investigation in nine French healthcare establishments to assess the safety of the SECURIDRAP® SELFIA® bedding. This study follows the market withdrawal of the first version of this product and is carried out upon recommendation from the ASNM to evaluate the safety of the second version. The study involves patients with disorientation, cognitive impairment, or behavior disorders who have a medical prescription for the device. Participants will use the SECURIDRAP® SELFIA® bedding for 15 nights in real-life conditions within nursing homes and hospitals. During this time, an independent assessor will ensure that the device's usage conditions are properly followed. The study is interventional but non-comparative and is designed to pose minimal risks and constraints to participants. During the 15-night period, participants will be monitored for any adverse events related to the use of the SECURIDRAP® SELFIA®. Data collection will include safety evaluations to confirm the device's safe use in healthcare settings. The trial focuses on the occurrence rate of adverse events connected to the bedding's use, with close follow-up by researchers to ensure participant safety.