MIRA Device for Post Intensive Care Syndrome

Overseen By Christopher Santiago

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Not NSICU patient, No LAR

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Average 4 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the research team or your doctor.

What data supports the effectiveness of the MIRA treatment for Post Intensive Care Syndrome?

Research shows that sensory stimulation interventions can improve psychosocial and clinical outcomes for ICU patients, and reducing noise levels in ICU settings can enhance sleep quality. These findings suggest that the MIRA device, which provides multi-sensory stimulation, may help improve recovery for patients with Post Intensive Care Syndrome. ^{1 2 3 4 5}

How is the MIRA treatment different from other treatments for Post Intensive Care Syndrome?

The MIRA treatment is unique because it uses a multi-sensory stimulation approach, which involves stimulating multiple senses like touch and sound to improve alertness and arousal, unlike traditional treatments that may not focus on sensory stimulation. ^{3 6 7 8 9}

Research Team

Neha Dangayach

Principal Investigator

Principal Investigator

Eligibility Criteria

This trial is for adults aged 18 or older who are either patients currently admitted to the Mount Sinai Hospital NSICU with any diagnosis expected to stay at least 48 hours, or staff members working there. Participants must consent to study procedures and be available for the duration of the study.

Inclusion Criteria

My gender identity does not affect my eligibility.

Provision of signed and dated informed consent form (ICF)

I work in the NSICU and am 18 years old or older.

Exclusion Criteria

Not a Mount Sinai NSICU patient

No LAR present and unable to consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants experience the MIRA device during their stay in the NSICU

Average 4 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months

Treatment Details

Interventions

• MIRA

Trial Overview The MIRA device, a prototype Multi-Sensory Stimulation Device using audio-visual immersive experiences from SOLUNA software, is being tested in the NSICU setting. The goal is to assess its safety, feasibility, and impact on physical, mental, and cognitive health over a period of 12 months.

Participant Groups

Group I: MIRA in the NSICU Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

The Control arm will not experience the device.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

A sensory stimulation intervention in a surgical intensive care unit significantly reduced post-traumatic stress disorder symptoms, depressive symptoms, and delusional memories in patients compared to a control group, based on a study of 152 patient-caregiver dyads.

Family caregivers of patients who received sensory stimulation reported higher satisfaction with care and lower anxiety levels, indicating positive psychosocial effects for both patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a sensory stimulation intervention on psychosocial and clinical outcomes of critically ill patients and their families: A randomised controlled trial. Liang, S., Pak Chun Chau, J., Hoi Shan Lo, S., et al.[2023]

Architectural modifications in ICU rooms successfully reduced sound pressure levels, leading to a significant decrease in disruptive noise during nighttime, which is crucial for improving sleep quality in critically ill patients.

The study demonstrated that the modified ICU rooms had a more distinct day-night sound pattern, with fewer talking events at night, indicating that such changes can create a more healing environment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of noise reduction by a modification in ICU environment. Luetz, A., Weiss, B., Penzel, T., et al.[2017]

In a study of 88 non-ventilated, non-sedated critical care patients, the use of earplugs significantly improved subjective sleep satisfaction scores compared to a control group, indicating a positive impact on sleep quality.

Earplugs are a low-cost, non-invasive intervention that enhances sleep experience in critical care settings without disrupting patient care, making them a preferable alternative to sedative medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Earplugs improve patients' subjective experience of sleep in critical care. Scotto, CJ., McClusky, C., Spillan, S., et al.[2022]

In a study of 18 critical patients who had been in a coma and received ototoxic medications, 61% were found to have middle ear effusion, while 11% exhibited high-frequency sensorineural hearing loss, despite most patients not reporting any hearing issues.

The findings suggest that aminoglycoside toxicity may have caused the sensorineural hearing loss, highlighting the importance of using auditory brainstem response (ABR) testing to detect early hearing impairments and potentially prevent further damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term results of a hearing screening in critically ill patients dismissed from an intensive care unit]. Cavaliere, F., Masieri, S., Arcangeli, A., et al.[2010]

The study demonstrated that using earplugs in an ICU setting is feasible, with 95% of participants receiving them within 6 hours of admission, indicating high acceptability of the intervention.

The results suggest that earplugs could be a practical noise-abatement strategy to improve sleep for patients undergoing mechanical ventilation, paving the way for a larger definitive trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality sleep using earplugs in the intensive care unit: the QUIET pilot randomised controlled trial. Litton, E., Elliott, R., Ferrier, J., et al.[2017]

The study involved 89 patients aged 16-65 with severe brain injuries, focusing on the effects of a multimodal onset stimulation therapy (MEOS) administered during early rehabilitation after being in a coma for over 48 hours.

Significant improvements in vegetative parameters, such as heart and respiratory rates, were observed, particularly with tactile and acoustic stimulation, indicating that early sensory stimulation can positively impact recovery even in patients with deep coma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal early onset stimulation (MEOS) in rehabilitation after brain injury. Grüner, ML., Terhaag, D.[2019]

The Nemuri SCAN (NSCAN) device showed moderate agreement and high sensitivity compared to polysomnography (PSG) in measuring sleep in critically ill patients, indicating it could be a useful tool for sleep assessment in intensive care settings.

However, NSCAN's poor specificity suggests it struggles to accurately identify immobile wakefulness and sleep depth, which limits its effectiveness in evaluating subjective sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of an under-mattress sensor for objective sleep measurement in critically ill patients: a prospective observational study. Nagatomo, K., Masuyama, T., Iizuka, Y., et al.[2022]

In a pilot study involving six comatose patients, directed multisensory stimulation (SDS) showed greater responsiveness in eye movement and motor responses compared to non-directed stimulation (NDS), suggesting that targeted sensory interventions may be more effective.

The study utilized a single case methodology with an ABAB design, indicating that this approach can provide valuable insights into the effects of sensory stimulation in patients with severe brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of directed multisensory stimulation versus non-directed stimulation in comatose CHI patients: pilot study of a single subject design. Hall, ME., MacDonald, S., Young, GC.[2019]

Multimodal sensory stimulation has strong evidence supporting its effectiveness in improving arousal and clinical outcomes for individuals in a coma or persistent vegetative state following traumatic brain injury, based on a systematic review of studies published between 2008 and 2013.

Auditory stimulation showed moderate evidence of effectiveness, while more complex stimuli had limited evidence, indicating that tailored interventions should be frequent and sustained to maximize recovery potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Sensory Stimulation to Improve Arousal and Alertness of People in a Coma or Persistent Vegetative State After Traumatic Brain Injury: A Systematic Review. Padilla, R., Domina, A.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of a sensory stimulation intervention on psychosocial and clinical outcomes of critically ill patients and their families: A randomised controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of noise reduction by a modification in ICU environment. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Earplugs improve patients' subjective experience of sleep in critical care. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

[Long-term results of a hearing screening in critically ill patients dismissed from an intensive care unit]. [2010]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Quality sleep using earplugs in the intensive care unit: the QUIET pilot randomised controlled trial. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Multimodal early onset stimulation (MEOS) in rehabilitation after brain injury. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Validity of an under-mattress sensor for objective sleep measurement in critically ill patients: a prospective observational study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effectiveness of directed multisensory stimulation versus non-directed stimulation in comatose CHI patients: pilot study of a single subject design. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Sensory Stimulation to Improve Arousal and Alertness of People in a Coma or Persistent Vegetative State After Traumatic Brain Injury: A Systematic Review. [2022]