Neurosteer Bedside Monitoring System

Recruiting now · Not applicable

Conditions studied: Delirium, Sedation, Agitation

In brief

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.

Key facts

Study ID

NCT06718764

Run by

Icahn School of Medicine at Mount Sinai

People needed

100

Starts

2024-07-08

Expected to finish

2026-07-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai Hospital — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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