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

NCT06509815 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-10-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Neha Dangayach · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-25
Primary Completion
2025-07-12
Completion
2026-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509815 on ClinicalTrials.gov