Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232317
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-30
First Post:
2024-01-22
Brief Title:
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess the feasibility acceptability and safety of using ReCognitionVR virtual reality-based software in older surgical patients Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium
Detailed Description:
Virtual reality VR imitates reality by creating an artificial 3-dimensional 3D environment using computing technology or software A virtual environment VE is created using this software with a headset which cognitively stimulates the users brain to think they are in an artificial world Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE VR strengthens the brains ability to focus learn and retain experience VR for attention deficit disorders has been reported to have promising results We followed in similar footsteps and designed and developed a novel 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises
A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers NCT05583903 The results of this study showed that ReCognitionVR-based cognitive exercises were feasible acceptable and tolerable by older healthy subjects In stage 2 of our research study we want to evaluate the safety feasibility acceptability and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital HMH Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation attention memory and executive functions The system will allow customized frequency and duration of cognitive exercises based on the users difficulty level in a delightfully relaxed environment with beach wave sounds
A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers NCT05583903 The results of this study showed that ReCognitionVR-based cognitive exercises were feasible acceptable and tolerable by older healthy subjects In stage 2 of our research study we want to evaluate the safety feasibility acceptability and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital HMH Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation attention memory and executive functions The system will allow customized frequency and duration of cognitive exercises based on the users difficulty level in a delightfully relaxed environment with beach wave sounds
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03AG078857 | NIH | None | httpsreporternihgovquickSearchR03AG078857 |