NCT06579378 Feasibility Study of Virtual Sail 3D in Cognitive Functions
| NCT ID | NCT06579378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cagliari |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-05-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.
Eligibility Criteria
Inclusion Criteria: * Age: 65 years or older * Sex: all * Living independently, * Without conditions that would prevent them from participating in the activities of the experimental intervention "VSail 3D," * Without severe issues with autonomous mobility * With Mild Cognitive Impairment (MCI) according to Addenbrooke's Cognitive Examination for cognitive functions (ACE-R), which also includes the Mini-Mental State Examination (MMSE), with the following ranges: ACE = 66.93-79.86 and/or MMSE = 21-25. * Signing the informed consent Exclusion Criteria: * severe cardiovascular conditions * severe issues with autonomous mobility * severe metabolic disorders not pharmacologically compensated * severe neurological conditions that prevent from participating in the experimental protocol, such as a stroke within the past 2 years, Parkinson's disease, epilepsy, or dementia (Alzheimer's, vascular, etc.) * severe ongoing bronchopulmonary disorders * severe ongoing renal disorders * glaucoma, retinal detachment, or other serious vision conditions that do not allow the safe use of 3D virtual reality technology * active malignant neoplasm that do not allow the hinders participation in the intervention.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06579378 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06579378 currently recruiting?
Yes, NCT06579378 is actively recruiting participants. Contact the research team at federicasancassiani@yahoo.it for enrollment information.
Where is the NCT06579378 trial being conducted?
This trial is being conducted at Cagliari, Italy.
Who is sponsoring the NCT06579378 clinical trial?
NCT06579378 is sponsored by University of Cagliari. The trial plans to enroll 40 participants.