Neurosteer Bedside Monitoring System
Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Dec 4, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new brain monitoring device called the Neurosteer Bedside Monitoring System. The aim is to see how well this device can help doctors monitor patients in the Intensive Care Unit (ICU) who are experiencing delirium, sedation, or agitation. The study will involve 100 patients, half of whom will have specific types of brain injuries, while the other half will not. All patients will wear the Neurosteer device on their forehead to collect data during their stay in the ICU.
To participate, patients must be at least 18 years old, be on a ventilator for at least 48 hours, and agree to the study procedures. However, those with certain conditions, like severe hearing problems or severe dementia, won't be eligible. Throughout the study, doctors will compare the readings from the Neurosteer device with standard assessments of sedation and agitation that are usually done in the ICU. Participants can expect to wear the device and receive auditory stimulation through earphones several times a day to help gather the necessary information. This research could lead to better ways to monitor and treat ICU patients.
Gender
ALL
Eligibility 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
About Icahn School Of Medicine At Mount Sinai
The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
Principal Investigator
Icahn School of Medicine at Mount Sinai
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported