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

Mount Sinai Health System

Status: Active, not recruiting

Conditions: Post Intensive Care Syndrome

Treatments: Device: MIRA

Study type: Interventional

Funder types: Other

Identifiers

NCT06509815

STUDY-23-00967

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

MIRA in the NSICU

Experimental group

Description:

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

Treatment:

Device: MIRA

Control

No Intervention group

Description:

The Control arm will not experience the device.