Post Intensive Care SyndromeNCT06509815
Multi-sensory Intervention Room Application (MIRA) Device in the NSICU
A study testing MIRA in people with Post Intensive Care Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome
- What is being tested?
- MIRA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Not a Mount Sinai NSICU patient
- No LAR present and unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post Intensive Care Syndrome
- Being tested
- MIRA
- Keywords
- Post Intensive Care Syndrome, Bio-Experiential Space, Biophilic Design
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MIRA in the NSICU | Experimental | The Intervention arm will experience the device, MIRA, during their stay in the NSICU. Receives: Device: MIRA |
| Control | No intervention | The Control arm will not experience the device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start25 Aug 2024
- Primary completion12 Jul 2025
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neha Dangayach, Icahn School of Medicine at Mount Sinai
- Investigators
- Neha Dangayach, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509815
- Sponsor's protocol ID
- STUDY-23-00967
- Status last verified
- Oct 2025
- First submitted
- 2 May 2024
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Efficacy of a Bio-experiential Intervention, Multi-sensory Intervention Room Application (MIRA), During Neurosciences ICU Stay
- ClinicalTrials.gov ID
- NCT06509815
- Acronym / sponsor ID
- STUDY-23-00967
- Conditions
- Post Intensive Care Syndrome
- Keywords
- Post Intensive Care Syndrome, Bio-Experiential Space, Biophilic Design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIRA in the NSICU | Experimental | Device: MIRAThe Intervention arm will experience the device, MIRA, during their stay in the NSICU. |
| Control | No intervention | –The Control arm will not experience the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Current employee at NSICU
- Aged >/= 18
- 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)
Key exclusion criteria (2 listed)
- Not a Mount Sinai NSICU patient
- No LAR present and unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIRAThe 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. | Device | MIRA in the NSICU |
Primary outcome
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.
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.
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.
16 secondary outcomes
Intubated pain measured using Critical Care Pain Observation Tool
Time frame: daily, average 4 days in ICU
Non-intubated pain measured using Pain Scale
Time frame: daily, average 4 days in ICU
Type of pain medication administration
Time frame: daily, average 4 days in ICU
Generalized Anxiety Disorder 7 Scale Score
Time frame: Baseline, Day 0
Generalized Anxiety Disorder 7 Scale Score
Time frame: At Discharge, approximately 4 days
Generalized Anxiety Disorder 7 Scale Score
Time frame: Up to 6 months
Patient Health Questionnaire 2 (PHQ2) Scale Score
Time frame: Baseline, Day 0
Patient Health Questionnaire 2 (PHQ2) Scale Score
Time frame: At Discharge, approximately 4 days
Patient Health Questionnaire 2 (PHQ2) Scale Score
Time frame: Up to 6 months
Patient Health Questionnaire 9 (PHQ9) Scale Score
Time frame: Baseline, Day 0
Patient Health Questionnaire 9 (PHQ9) Scale Score
Time frame: At Discharge, approximately 4 days
Patient Health Questionnaire 9 (PHQ9) Scale Score
Time frame: Up to 6 months
Awareness of person, place, and time
Time frame: Up to 6 months
Motor Status
Time frame: Up to 6 months
Response to noxious stimuli and/or touch
Time frame: Up to 6 months
Insomnia Severity Index to measure sleep quality
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Dangayach principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRA in people with Post Intensive Care Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Within 2 days of the device used in the patient room during stay in ICU). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.