Monitoring brain activity in ICU patients with sedation and delirium
Official title: Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
Run by Icahn School of Medicine at Mount Sinai · NCT06718764 · Data updated 2026-11-12
This study is testing a new brain monitoring device to see if it can help doctors better understand sedation and delirium in patients who are intubated and sedated in the ICU.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | July 8, 2024 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06718764 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are mechanically ventilated patients aged 18 and older who are expected to be on sedative drips for at least 48 hours.
✕Probably not a fit
Patients with severe dementia, known hearing problems, or those expected to withdraw life-sustaining therapy within 24-48 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Neurosteer's brain monitoring platform in assessing delirium, sedation, and agitation in intubated and sedated patients in the NSICU. A total of 100 patients will be enrolled, with half having Acute Neurological Injuries (ANI) and the other half not. The Neurosteer device will be used to collect EEG data and compare it with established scales for sedation and delirium. The goal is to determine if the device's readings correlate well with traditional monitoring methods.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring of sedation and delirium in critically ill patients, leading to better management and outcomes.
How similar studies have gone: While similar approaches have been explored, this specific application of Neurosteer's technology in ICU settings is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Mount Sinai Hospital
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21 — Icahn School of Medicine at Mount Sinai
- Study coordinator: Leslie Melo, MPH
- Email: leslie.melo@mountsinai.org
- Phone: 212-241-3376
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.