NCT07585500 Virtual Reality for Recovery After Intensive Care (PICS)
| NCT ID | NCT07585500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minho |
| Condition | Post-Intensive Care Syndrome (PICS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-12-06 |
| Primary Completion | 2026-05 |
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 51 participants in total. It began in 2025-12-06 with a primary completion date of 2026-05.
⚠ 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
The goal of this clinical trial is to learn if virtual reality (VR) helps improve thinking and memory skills in adults who have stayed in the intensive care unit (ICU). The study focuses on people who needed a breathing machine or stayed in the ICU for several days and are at risk for memory or "brain fog" issues. The main questions it aims to answer are: * Does using VR improve a participant's memory, attention, and thinking skills after an ICU stay? * Does the "immersive" feel of a VR headset work better to improve these skills than using a handheld tablet? Researchers will compare three groups to see how different types of care affect the brain: * VR-Rehab: Participants use a VR headset to play brain-training games. * Tablet-Rehab: Participants use a handheld tablet to play the same brain-training games. * Standard Care: Participants receive the usual hospital care without digital brain games. Participants will: * Play brain-training games for 12 minutes every day for up to one week while in the hospital. * Complete memory and thinking tests with a researcher at the start of the study and again after two weeks. * Answer follow-up questions about their memory and thinking skills for 6 months after leaving the hospital.
Eligibility Criteria
Inclusion Criteria: * Adult patients, 18 years or older * Patients in the Intensive Care Unit * Ventilated patients must be in the post-extubation period * The patient has a projected remaining hospital stay of at least 4 days (assessed by the clinical team) * The patient has RASS score between -1 and +1 * The patient has the ability to move both arms, even if with difficulties, as assessed by the clinical team, to be able to interact with the software * The patient can maintain a stable sitting position (30° to 60°) * The patient is able to communicate (speech, gesturing, or writing) * The patient can communicate and understand Portuguese * The patient or a legal representative provided informed consent Exclusion Criteria: * Severe cognitive and neurodegenerative diseases: mental illness requiring institutionalization; acquired or congenital intellectual disability; known severe brain injuries (e.g., stroke with significant residual deficits); moderate to severe Traumatic Brain Injury (TBI) (defined by the duration of loss of consciousness/post-traumatic amnesia or documented residual deficits); diagnosed neurodegenerative diseases (e.g., Parkinson's disease with severe movement impairment, Huntington's disease, severe Alzheimer's disease, or dementia of any etiology that prevents autonomy in daily life at baseline) * The patient uses neuromuscular blocking agents * The patient has a positive CAM-ICU result at the time of initial screening * The patient has active psychotic disorders or suicidal ideation * The patient has documented epilepsy or history of seizures * The patient has a "Do Not Resuscitate" (DNR) order, is on life support with exclusive focus on comfort, or has an unexpected survival predicted to be less than 24 hours * The patient has intoxication by an active substance or withdrawal syndrome requiring ongoing medical management that prevents safe and meaningful participation or accurate cognitive assessment * Patients with immobility or severe motor limitations in the upper limbs, fine motor skills, or cervical region * The patient has open wounds on the head or face that may affect the comfortable/safe use of VR glasses, cause discomfort, or present a hygiene risk * The patient has uncorrected blindness or deafness that prevents the safe/effective use of VR/tablet devices. * Patients are participating in another rehabilitation study with interventions * Patients with a scheduled surgery where the ICU stay is expected to be less than 24 hours * Patients in need of respiratory support
Contact & Investigator
João Ferreira-Coimbra, MD
PRINCIPAL INVESTIGATOR
Centro Hospitalar De São João, E.P.E.
Frequently Asked Questions
Who can join the NCT07585500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Intensive Care Syndrome (PICS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07585500 currently recruiting?
Yes, NCT07585500 is actively recruiting participants. Contact the research team at nunofeixa@gmail.com for enrollment information.
Where is the NCT07585500 trial being conducted?
This trial is being conducted at Porto, Portugal.
Who is sponsoring the NCT07585500 clinical trial?
NCT07585500 is sponsored by University of Minho. The principal investigator is João Ferreira-Coimbra, MD at Centro Hospitalar De São João, E.P.E.. The trial plans to enroll 51 participants.