NCT06693193 · NOT YET RECRUITING
Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study
This small Italian study tests whether virtual reality headsets can be used with elderly care-home residents who have cognitive impairment, when agitation or other difficult behaviors arise, such as during personal hygiene. Researchers are checking whether people tolerate it, stay with it, and enjoy it, and whether it is safe. It is an early feasibility study, not a test of whether it works.
You may qualify if
- Adults over 18 years of age.
- Native Italian speakers.
- Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.
You're excluded if
- Presence of any psychiatric diagnoses as recorded in medical records.
- A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
- A partial NPI score > 6 in the domains of agitation/aggression or delusions.
- Enrollment in palliative care services.
- Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
- Presence of a cardiac pacemaker or other metallic devices.
- Infectious or gastrointestinal disorders.
- Open facial wounds, motor or visual impairments, or neuromuscular pain that would prevent using the Oculus VR headset.
- Refusal to consent, either by the individual or their legal representative, for study participation.
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 2024-11-18