Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06718764

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

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 stay at least 48 hours on sedative medications such as 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 forehead
  • History of polysubstance abuse
  • Severe dementia
  • Anticipated withdrawal of life-sustaining therapy within 24 to 48 hours

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility assessment

Implementation

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

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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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