Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509815
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-02
Brief Title:
Multi-sensory Intervention Room Application MIRA Device in the NSICU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Feasibility and Efficacy of a Bio-experiential Intervention Multi-sensory Intervention Room Application MIRA During Neurosciences ICU Stay
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine the safety feasibility and efficacy of a device MIRA on the physical mental and cognitive health of Neurosciences Intensive Care Unit NSICU patients
The study device is a Multi-Sensory Stimulation Device named MIRA which uses commercially available hardware and builds off the SOLUNA software created by Studio Elsewhere which produces audio and visual immersive experiences The current device Model M1 is a prototype developed for sole investigational purposes of this study and is not commercially available
Participants who will be patients and staff of the NSICU will complete questionnaires regarding safety feasibility and efficacy The research team will enroll 20 patient and 15 staff participants The trial is expected to last 12 months
The study device is a Multi-Sensory Stimulation Device named MIRA which uses commercially available hardware and builds off the SOLUNA software created by Studio Elsewhere which produces audio and visual immersive experiences The current device Model M1 is a prototype developed for sole investigational purposes of this study and is not commercially available
Participants who will be patients and staff of the NSICU will complete questionnaires regarding safety feasibility and efficacy The research team will enroll 20 patient and 15 staff participants The trial is expected to last 12 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None