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Taking people in United StatesNo phase

Neurosteer Bedside Monitoring System

Key facts

Who runs it
Icahn School of Medicine at Mount Sinai
Where
New York, United StatesSee the site
Trial code
Status
Recruiting
People taking part
100 people, planned
Started
8 Jul 2024
Expected to end
Mar 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Neurosteer's single-channel EEG monitoring device
Record updated
28 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Anticipated Withdrawing Life-Sustaining Therapy (WLST) within the next 24-48 hours
  • History of polysubstance abuse
  • Severe dementia
  • Has known hearing problems and usage of hearing aids
  • Has a rash on forehead

Where in United States

  • Mount Sinai HospitalNew York, United StatesContact: Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • NSICU Patients with Acute Neurological Injuries (ANI)Existing treatment, for comparison

    ANI are participants having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. All participants will be set up with the Neurosteer bedside monitoring system.

    Treatment: Neurosteer's single-channel EEG monitoring device

  • NSICU Patients without Acute Neurological Injuries (ANI)Existing treatment, for comparison

    Participants without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. All participants will be set up with the Neurosteer bedside monitoring system.

    Treatment: Neurosteer's single-channel EEG monitoring device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
Record updated
28 September 2026