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Neurosteer Bedside Monitoring System

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later Jul 2026 → Mar 2028
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

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  1. Notable Primary and study completion pushed from Jul 2026 to Mar 2028 Show 5 more changesShow less
    • Interventions: Neurosteer's single-channel EEG monitoring device (Device) to Neurosteer's single-channel EEG monitoring device (Device)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
    • Study description expanded, about 4 words
  2. Notable Primary and study completion dates: Jul 2025 to Jul 2026
    • Site contact updated
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06718764
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Neurosteer Ltd.
Conditions
(from sponsor)
Delirium, Sedation, Agitation
Related terms Delirium, Psychomotor Agitation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov