Actively Recruiting
Neurosteer Bedside Monitoring System
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-04
100
Participants Needed
1
Research Sites
103 weeks
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
The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients. The research team will be conducting a single-site study. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have Acute Neurological Injuries (ANI) and the other 50 will not have an ANI. All enrolled patients will receive the intervention, the Neurosteer brain monitoring device. The study intervention consists of the use of Neurosteer's innovative single-channel EEG monitoring device to determine if there is a good correlation and agreement between their signals/parameters to RASS, CAM-ICU, and continuous EEG monitoring readings. The Neurosteer device will be attached to their forehead and readings will be collected for the duration of their NSICU stay. The research team will adapt the current physical methods of detecting the depth of anesthesia i.e. through the Richmond Agitation-Sedation Scale (RASS) \& CAM-ICU, to auditory stimulation, which will be delivered through earphones with no physical contact, with the aim of achieving a high correlation between the methods. RASS and CAM-ICU will be collected hourly as standard of care and Neurosteer auditory stimulation will be done 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU. The research team will correlate collected hourly RASS and CAM-ICU assessments with Neurosteer derived signals and parameters.
CONDITIONS
Official 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 need sedation drips for 48 hours or more, including drugs like propofol, midazolam, dexmedetomidine, fentanyl, dialudid, or ketamine
You will not qualify if you...
- Known hearing problems or use of hearing aids
- Rash on the forehead
- History of polysubstance abuse
- Severe dementia
- Expected withdrawal of life-sustaining therapy within 24 to 48 hours
AI-Screening
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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
CONTACT
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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