Neurosteer Bedside Monitoring System

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06718764
Status
Recruiting
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Conditions

  • Agitation
  • Delirium
  • Sedation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurosteer's single-channel EEG monitoring device — 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.

Study Details

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 Dates

Start date
Jul 8, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
[email protected]
212-241-3374
Leslie Melo, MPH
[email protected]
Neha S Dangayach (PRINCIPAL_INVESTIGATOR)

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Mount Sinai Hospital· New York, NY

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