NCT06509815

Multi-sensory Intervention Room Application (MIRA) Device in the NSICU

Safety, Feasibility, and Efficacy of a Bio-experiential Intervention, Multi-sensory Intervention Room Application (MIRA), During Neurosciences ICU Stay

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Intensive Care Syndrome

Interventions

Type	Name	Description
DEVICE	MIRA	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. The device produces audio and visual stimuli of immersive experiences. Participants in the intervention group will either have periodic or scheduled intervention sessions. The study team member will roll the MIRA device into the patient participant's room before the session and roll it out after. The intervention requires the participant to be in bed. The study team member will set up the device and start the intervention session which can last between 15-60 minutes. During the session, data will be collected by the study team member.

Timeline

• Start date: 2024-08-25
• Primary completion: 2025-07-12
• Completion: 2026-01-01
• First posted: 2024-07-19
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States