Recruiting

Neurosteer

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06718764

Conditions

Delirium

Sedation

Agitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurosteer's single-channel EEG monitoring device

Study Details

Brief summary:

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

Delirium

Sedation

Agitation

Study ID

NCT06718764

Start date

Jul 8, 2024

Status verified date

Aug, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: NSICU Patients with Acute Neurological Injuries (ANI)

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.

active comparator: NSICU Patients without Acute Neurological Injuries (ANI)

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.

Interventions

Neurosteer's single-channel EEG monitoring device

Neurosteer device will be attached to participants forehead and readings will be collected for the duration of their NSICU stay.

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.

Primary outcome measure

  • Sedation as measured by Richmond Agitation Sedation Scale [ Time Frame: 3-4 times daily throughout participants NSICU stay (average 14 days) ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21

212-241-3374neha.dangayach@mountsinai.org

Principal Investigator:

Neha S Dangayach

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 4, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-04.