NCT05649839 · ACTIVE NOT RECRUITING
Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders
This trial is testing a newly designed adaptive garment for people with dementia who have incontinence and behavioral problems that lead them to remove standard protective garments. The goal is to create something dignified and aesthetically acceptable that works during the day, not just at night. This is a prototype design and feasibility study, not a drug trial and not yet proven at scale.
You may qualify if
- Patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the EHPAD at the St-Victor center - CHU Amiens-Picardie,
- patients with behavioral and sphincter disorders justifying the prescription of a romper.
- signature of a consent exclusion criteria
You're excluded if
- No next of kin
- Patients in terminal palliative care
- Patients whose morphology does not allow the use of prototypes (no adapted size)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-19