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

NCT06509815 | Active Not Recruiting

• 1 other identifier: STUDY-23-00967
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Syndrome

Keywords

Post Intensive Care Syndrome; Bio-Experiential Space; Biophilic Design

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  Implementation success will be assessed using the Acceptability of Intervention Measure (AIM). AIM is a 4-item measure used to determine the extent to which stakeholders (e.g., parents, providers, administrators) believe an intervention or implementation strategy is acceptable. Total score ranges from a minimum score 4 (unacceptable) to a maximum score 20 (very acceptable), with higher scores indicating greater acceptability of the intervention.

  Within 2 days of the device used in the patient room during stay in ICU

• Intervention Appropriateness Measure (IAM)

  Implementation success will be assessed using the Intervention Appropriateness Measure (IAM). IAM is a 4-item measure used to determine the extent to which stakeholders (e.g. parents, providers, administrators) believe an intervention or implementation strategy is appropriate or suitable for the situation. Total score ranges minimum 4 (unacceptable) to maximum 20 (very acceptable), with higher scores indicating greater appropriateness of the intervention strategy being evaluated.

  Within 2 days of the device used in the patient room during stay in ICU

• Feasibility of Intervention Measure (FIM)

  Implementation success will be assessed using the Feasibility of Intervention Measure (FIM). FIM is a 4-item measure used to determine the extent to which an intervention or implementation strategy is feasible to implement. Total score ranges from a minimum of 4 (not feasible) to a maximum of 20 (very feasible), with higher scores indicating greater perceived feasibility of the intervention strategy being evaluated.

  Within 2 days of the device used in the patient room during stay in ICU

Secondary Outcomes (16)

• Intubated pain measured using Critical Care Pain Observation Tool

  daily, average 4 days in ICU

• Non-intubated pain measured using Pain Scale

  daily, average 4 days in ICU

• Type of pain medication administration

  daily, average 4 days in ICU

• Generalized Anxiety Disorder 7 Scale Score

  Baseline, Day 0

• Generalized Anxiety Disorder 7 Scale Score

  At Discharge, approximately 4 days

Study Arms (2)

MIRA in the NSICU

EXPERIMENTAL

The Intervention arm will experience the device, MIRA, during their stay in the NSICU.

Device: MIRA

Control

NO INTERVENTION

The Control arm will not experience the device.

Interventions

MIRA DEVICE

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.

MIRA in the NSICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• For NSICU Staff:
• Current employee at NSICU
• Aged \>/= 18
• For NSICU Patients:
• Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours
• Provision of signed and dated informed consent form (ICF)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Aged \>/= 18
• Any sex or gender identity
• Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours

You may not qualify if:

• Not a Mount Sinai NSICU patient
• No LAR present and unable to consent

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Neha Dangayach

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: July 19, 2024
• Study Start: August 25, 2024
• Primary Completion: July 12, 2025
• Study Completion: January 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)