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NCT06509815 · ClinicalTrials.gov registry record · NA
Multi-sensory Intervention Room Application (MIRA) Device in the NSICU
A NA study of Post-Intensive Care Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT06509815: Active NA study of Post-Intensive Care Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06509815 is a NA study of Post-Intensive Care Syndrome that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 34 participants, below the 188-participant average among 5 other Post-Intensive Care Syndrome trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06509815, a NA study of Post-Intensive Care Syndrome, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE MIRA
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-08-25 |
| Est. Completion | 2026-01 |
| Phase | NA |
What the registry record for NCT06509815 still lists
NCT06509815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 188-participant average among 5 other Post-Intensive Care Syndrome trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Post-Intensive Care Syndrome appearing as the primary indexed condition, and to 1 intervention - of which MIRA is the first listed.
NCT06509815 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06509815 about?
NCT06509815 is a clinical study titled "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...
What is the current status of trial NCT06509815?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 34 participants. The study started on 2024-08-25. Estimated completion is 2026-01.
What conditions does trial NCT06509815 study?
This clinical trial studies the following conditions: Post-Intensive Care Syndrome.
What interventions are being tested in trial NCT06509815?
The interventions under investigation include: MIRA (DEVICE).
Who is sponsoring clinical trial NCT06509815?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06509815 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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