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NCT06718764 · ClinicalTrials.gov registry record · NA
Neurosteer Bedside Monitoring System
A NA study of Delirium and Sedation, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06718764: Recruiting NA study of Delirium and Sedation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06718764 is a NA study of Delirium and Sedation that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants, below the 886-participant average among 62 other Delirium trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06718764, a NA study of Delirium and Sedation, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Richmond Agitation Sedation Scale (RASS) for measuring the depth of sedation in sedated, intubated critically ill patients. RASS scoring -5 to +4, is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation, where higher scores indicate higher levels of agitation. 4 Combative, violent, danger to staff 3 Pulls or removes tube(s) or catheters; aggressive 2 Frequent non-purposeful movement 1 Anxious, apprehensive, but not aggressive 0 Alert and calm 1. Aw
Interventions
- DEVICE Neurosteer's single-channel EEG monitoring device
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-07-08 |
| Est. Completion | 2025-07 |
| Phase | NA |
What NCT06718764 shows while recruiting
NCT06718764 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 886-participant average among 62 other Delirium trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Delirium appearing as the primary indexed condition, and to 1 intervention - of which Neurosteer's single-channel EEG monitoring device is the first listed.
NCT06718764 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06718764 about?
NCT06718764 is a clinical study titled "Neurosteer Bedside Monitoring System". 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 admitte...
What is the current status of trial NCT06718764?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-07-08. Estimated completion is 2025-07.
What conditions does trial NCT06718764 study?
This clinical trial studies the following conditions: Delirium, Sedation, Agitation.
What interventions are being tested in trial NCT06718764?
The interventions under investigation include: Neurosteer's single-channel EEG monitoring device (DEVICE).
Who is sponsoring clinical trial NCT06718764?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06718764 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06718764's enrollment target sits among peer trials
100 38th of 62 higher than 21 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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