Clinical trial NCT06509815: Multi-sensory Intervention Room Application (MIRA) Device in the NSICU
Official title: Safety, Feasibility, and Efficacy of a Bio-experiential Intervention, Multi-sensory Intervention Room Application (MIRA), During Neurosciences ICU Stay
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Intensive Care Syndrome
Keywords: Post Intensive Care Syndrome
Bio-Experiential Space
Biophilic Design
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Within 2 days of the device used in the patient room during stay in ICU
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Within 2 days of the device used in the patient room during stay in ICU
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Within 2 days of the device used in the patient room during stay in ICU
Secondary outcomes:
measure: Intubated pain measured using Critical Care Pain Observation Tool
timeFrame: daily, average 4 days in ICU
measure: Non-intubated pain measured using Pain Scale
timeFrame: daily, average 4 days in ICU
measure: Type of pain medication administration
timeFrame: daily, average 4 days in ICU
measure: Generalized Anxiety Disorder 7 Scale Score
timeFrame: Baseline, Day 0
measure: Generalized Anxiety Disorder 7 Scale Score
timeFrame: At Discharge, approximately 4 days
measure: Generalized Anxiety Disorder 7 Scale Score
timeFrame: Up to 6 months
measure: Patient Health Questionnaire 2 (PHQ2) Scale Score
timeFrame: Baseline, Day 0
measure: Patient Health Questionnaire 2 (PHQ2) Scale Score
timeFrame: At Discharge, approximately 4 days
measure: Patient Health Questionnaire 2 (PHQ2) Scale Score
timeFrame: Up to 6 months
measure: Patient Health Questionnaire 9 (PHQ9) Scale Score
timeFrame: Baseline, Day 0
measure: Patient Health Questionnaire 9 (PHQ9) Scale Score
timeFrame: At Discharge, approximately 4 days
measure: Patient Health Questionnaire 9 (PHQ9) Scale Score
timeFrame: Up to 6 months
measure: Awareness of person, place, and time
timeFrame: Up to 6 months
measure: Motor Status
timeFrame: Up to 6 months
measure: Response to noxious stimuli and/or touch
timeFrame: Up to 6 months
measure: Insomnia Severity Index to measure sleep quality
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Principal Investigator
name: Neha Dangayach
role: PRINCIPAL_INVESTIGATOR
References: