Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06718764

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

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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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