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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Intensive Care Syndrome
• Intervention / Treatment: Device: MIRA

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIRA in the NSICU; The Intervention arm will experience the device, MIRA, during their stay in the NSICU.	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.
No Intervention: Control; The Control arm will not experience the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubated pain measured using Critical Care Pain Observation Tool	The Critical Care Pain Observation Tool (CCPOT) is an 8-item measure used to assess self-reported pain levels in intubated, critically ill patients who cannot self-report. Total CCPOT score ranges from a minimum of 0 (no pain behaviors observed) to a maximum of 8 (significant behaviors indicating severe pain), with higher scores indicating higher pain levels in intubated patients.	daily, average 4 days in ICU
Non-intubated pain measured using Pain Scale	The Pain Scale is used to assess self-reported pain levels in critically ill patients who are not intubated and can self-report pain. Total score on the Pain Scale ranges from a minimum of 0 (no pain) to a maximum of 10 (worst/most severe pain), with higher scores indicating more intense pain levels in non-intubated patients.	daily, average 4 days in ICU
Type of pain medication administration	Categorical information on the type of medication administered (sedatives, analgesics, anti-seizure medications, anti-hypertensives, pressors, antibiotics, antipsychotics, other)	daily, average 4 days in ICU
Generalized Anxiety Disorder 7 Scale Score	The Generalized Anxiety Disorder 7-item (GAD-7) scale is used to assess self-reported anxiety symptoms. Total GAD-7 score ranges from a minimum of 0 (no anxiety) to a maximum of 21 (severe anxiety), with higher scores indicating greater anxiety severity.	Baseline, Day 0
Generalized Anxiety Disorder 7 Scale Score	The Generalized Anxiety Disorder 7-item (GAD-7) scale is used to assess self-reported anxiety symptoms. Total GAD-7 score ranges from a minimum of 0 (no anxiety) to a maximum of 21 (severe anxiety), with higher scores indicating greater anxiety severity.	At Discharge, approximately 4 days
Generalized Anxiety Disorder 7 Scale Score	The Generalized Anxiety Disorder 7-item (GAD-7) scale is used to assess self-reported anxiety symptoms. Total GAD-7 score ranges from a minimum of 0 (no anxiety) to a maximum of 21 (severe anxiety), with higher scores indicating greater anxiety severity.	Up to 6 months
Patient Health Questionnaire 2 (PHQ2) Scale Score	The Patient Health Questionnaire-2 (PHQ-2) is a 2-item screening tool used to assess depressed mood and anhedonia to screen for depression. PHQ-2 scores range from 0 to 6, with higher scores suggesting a higher likelihood of depression requiring further evaluation with the longer PHQ-9.	Baseline, Day 0
Patient Health Questionnaire 2 (PHQ2) Scale Score	The Patient Health Questionnaire-2 (PHQ-2) is a 2-item screening tool used to assess depressed mood and anhedonia to screen for depression. PHQ-2 scores range from 0 to 6, with higher scores suggesting a higher likelihood of depression requiring further evaluation with the longer PHQ-9.	At Discharge, approximately 4 days
Patient Health Questionnaire 2 (PHQ2) Scale Score	The Patient Health Questionnaire-2 (PHQ-2) is a 2-item screening tool used to assess depressed mood and anhedonia to screen for depression. PHQ-2 scores range from 0 to 6, with higher scores suggesting a higher likelihood of depression requiring further evaluation with the longer PHQ-9.	Up to 6 months
Patient Health Questionnaire 9 (PHQ9) Scale Score	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to assess depression severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.	Baseline, Day 0
Patient Health Questionnaire 9 (PHQ9) Scale Score	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to assess depression severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.	At Discharge, approximately 4 days
Patient Health Questionnaire 9 (PHQ9) Scale Score	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to assess depression severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.	Up to 6 months
Awareness of person, place, and time	Neurological assessment used to assess mental status. Mental status checks if a person has awareness of person, place, and time.	Up to 6 months
Motor Status	Neurological assessment used to asses motor status. Motor strength is ranked 0-5 (5 meaning full function) for both upper and lower extremities.	Up to 6 months
Response to noxious stimuli and/or touch	Neurological assessment used to assess sensory status. Sensory status notes if the patient responds to noxious stimuli or not.	Up to 6 months
Insomnia Severity Index to measure sleep quality	The Insomnia Severity Index (ISI) is a 7-item questionnaire used to assess perceived insomnia severity. ISI scores range from 0 to 28, with higher scores indicating more severe levels of insomnia.	Up to 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Neha Dangayach, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Actual): July 12, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Post Intensive Care Syndrome; Bio-Experiential Space; Biophilic Design
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; postintensive care syndrome
• Other Study ID Numbers: STUDY-23-00967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No