Actively Recruiting
Evaluating the Feasibility of Using Neurosteer's Brain Activity Monitor in the Neurosciences Intensive Care Unit
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-04
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
Neurosteer Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the clinical usefulness of Neurosteer's brain monitoring platform for tracking delirium, sedation, and agitation in intubated and sedated patients in the Neurosciences Intensive Care Unit (NSICU). The study will enroll 100 patients admitted to the NSICU, half with Acute Neurological Injuries (ANI) such as strokes, brain injuries, or infections, and half without ANI but with other critical illnesses. Researchers will compare the Neurosteer device's signals with standard assessments like the Richmond Agitation-Sedation Scale (RASS), Confusion Assessment Method (CAM-ICU), and continuous EEG monitoring. All participants will receive the Neurosteer single-channel EEG monitoring device, which will be placed on their forehead for continuous monitoring during their NSICU stay. Auditory stimulation through earphones will be delivered 3-4 times daily alongside RASS assessments and 1-2 times daily with CAM-ICU assessments. The study will track correlations between Neurosteer readings and traditional measures of sedation and delirium. The intervention lasts for the entire NSICU admission, averaging around 14 days. Participants will be closely monitored with hourly RASS and CAM-ICU evaluations, continuous EEG for some, and Neurosteer device recordings. Data will be collected throughout their stay to analyze sedation depth and delirium presence. The study includes statistical analyses during and after enrollment. Informed consent will be obtained from patients or their representatives. Researchers will compare results within and between patient groups with and without ANI to evaluate the monitoring platform's performance.
CONDITIONS
Brief Title
Neurosteer Bedside Monitoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from patient or legally authorized representative
- Any sex at birth, including transgender or intersex individuals
- Age 18 years or older
- Mechanically ventilated patients expected to stay at least 48 hours on sedative medications such as propofol, midazolam, dexmedetomidine, fentanyl, dialudid, or ketamine
You will not qualify if you...
- Known hearing problems or use of hearing aids
- Rash on forehead
- History of polysubstance abuse
- Severe dementia
- Anticipated withdrawal of life-sustaining therapy within 24 to 48 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Duration of NSICU stay (average 14 days)
Participants have the Neurosteer brain monitoring device attached to their forehead for continuous monitoring during their stay in the Neurosciences Intensive Care Unit (NSICU). Auditory stimulation is done multiple times daily to coincide with sedation and delirium assessments.
Monitoring continuous throughout NSICU stay with 3-4 daily sedation assessments and 1-2 daily delirium assessments
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
L
Leslie Melo, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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