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Active, Not Recruiting

NCT Number: NCT06509815

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post Intensive Care Syndrome postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of Intervention Measure (AIM)

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

    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.

  2. Intervention Appropriateness Measure (IAM)

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

    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.

  3. Feasibility of Intervention Measure (FIM)

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

    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.

Secondary outcomes

  1. Intubated pain measured using Critical Care Pain Observation Tool

    Time frame: daily, average 4 days in ICU

    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.

  2. Non-intubated pain measured using Pain Scale

    Time frame: daily, average 4 days in ICU

    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.

  3. Type of pain medication administration

    Time frame: daily, average 4 days in ICU

    Categorical information on the type of medication administered (sedatives, analgesics, anti-seizure medications, anti-hypertensives, pressors, antibiotics, antipsychotics, other)

  4. Generalized Anxiety Disorder 7 Scale Score

    Time frame: Baseline, Day 0

    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.

  5. Generalized Anxiety Disorder 7 Scale Score

    Time frame: At Discharge, approximately 4 days

    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.

  6. Generalized Anxiety Disorder 7 Scale Score

    Time frame: Up to 6 months

    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.

  7. Patient Health Questionnaire 2 (PHQ2) Scale Score

    Time frame: Baseline, Day 0

    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.

  8. Patient Health Questionnaire 2 (PHQ2) Scale Score

    Time frame: At Discharge, approximately 4 days

    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.

  9. Patient Health Questionnaire 2 (PHQ2) Scale Score

    Time frame: Up to 6 months

    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.

  10. Patient Health Questionnaire 9 (PHQ9) Scale Score

    Time frame: Baseline, Day 0

    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.

  11. Patient Health Questionnaire 9 (PHQ9) Scale Score

    Time frame: At Discharge, approximately 4 days

    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.

  12. Patient Health Questionnaire 9 (PHQ9) Scale Score

    Time frame: Up to 6 months

    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.

  13. Awareness of person, place, and time

    Time frame: Up to 6 months

    Neurological assessment used to assess mental status. Mental status checks if a person has awareness of person, place, and time.

  14. Motor Status

    Time frame: Up to 6 months

    Neurological assessment used to asses motor status. Motor strength is ranked 0-5 (5 meaning full function) for both upper and lower extremities.

  15. Response to noxious stimuli and/or touch

    Time frame: Up to 6 months

    Neurological assessment used to assess sensory status. Sensory status notes if the patient responds to noxious stimuli or not.

  16. Insomnia Severity Index to measure sleep quality

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Safety, Feasibility, and Efficacy of a Bio-experiential Intervention, Multi-sensory Intervention Room Application (MIRA), During Neurosciences ICU Stay

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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