Neurosteer Bedside Monitoring System for ICU Patients

This study is testing a new brain monitoring system called Neurosteer to see how well it can track delirium, sedation, and agitation in patients who are in the intensive care unit (ICU) and on a breathing machine. The Neurosteer device is a single-channel EEG (electroencephalogram) monitor that will be placed on your forehead. Researchers want to see if the readings from this device match up with standard ways of measuring sedation (Richmond Agitation Sedation Scale or RASS) and delirium (Confusion Assessment Method for the ICU or CAM-ICU). They will also compare it to continuous EEG monitoring. The study plans to enroll 100 patients, some with brain injuries and some without, to see if the device works similarly for both groups. The goal is to find out if the Neurosteer system can be a useful tool for monitoring these conditions.

Study design
This is an interventional study enrolling 100 participants. All enrolled patients will receive the Neurosteer brain monitoring device.
What's involved
The Neurosteer device will be attached to your forehead, and readings will be collected for the duration of your NSICU stay. You will also receive Neurosteer auditory stimulation 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU.
Compensation
Not stated in the trial record.
Follow-up
Sedation will be measured 3-4 times daily throughout your NSICU stay, which is expected to average 14 days.

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NCT06718764

Neurosteer Bedside Monitoring System

Recruiting
NAAges 18+InterventionalBasic science
Icahn School of Medicine at Mount Sinai
~100 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Neurosteer's single-channel EEG monitoring device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sedation as measured by Richmond Agitation Sedation Scale
Measured over 3-4 times daily throughout participants NSICU stay (average 14 days)
Delirium
Sedation
Agitation
1 sites across 1 states
New York1
  • Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21 · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form from patient and/or LAR, including stated willingness to comply with all study procedures and availability for the duration of the study
Any assigned sex at birth, including individuals who are transgender or intersex
Age 18 years or older
Mechanically ventilated patients with an anticipated LOS \>/=48 hours on any sedative drips including propofol, midazolam, dexmedetomidine, fentanyl, dialudid, ketamine

Exclusion

Has known hearing problems and usage of hearing aids
Has a rash on forehead
History of polysubstance abuse
Severe dementia
Anticipated Withdrawing Life-Sustaining Therapy (WLST) within the next 24-48 hours
  • Sedation as measured by Richmond Agitation Sedation Scale3-4 times daily throughout participants NSICU stay (average 14 days)

    Richmond Agitation Sedation Scale (RASS) for measuring the depth of sedation in sedated, intubated critically ill patients. RASS scoring -5 to +4, is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation, where higher scores indicate higher levels of agitation. 4 Combative, violent, danger to staff 3 Pulls or removes tube(s) or catheters; aggressive 2 Frequent non-purposeful movement 1 Anxious, apprehensive, but not aggressive 0 Alert and calm 1. Awakens to voice (eye opening/contact) \>10 sec 2. Light sedation, briefly awakens to voice (eye opening/contact) \<10 sec 3. Moderate sedation, movement or eye opening. No eye contact 4. Deep sedation, no response to voice, but movement or eye opening to physical stimulation 5. Unarousable, no response to voice or physical stimulation