RECRUITING

Neurosteer Bedside Monitoring System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit

Quick Facts

Study Start:2024-07-08
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06718764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Any assigned sex at birth, including individuals who are transgender or intersex
  3. * Age 18 years or older
  4. * Mechanically ventilated patients with an anticipated LOS \>/=48 hours on any sedative drips including propofol, midazolam, dexmedetomidine, fentanyl, dialudid, ketamine
  1. * Has known hearing problems and usage of hearing aids
  2. * Has a rash on forehead
  3. * History of polysubstance abuse
  4. * Severe dementia
  5. * Anticipated Withdrawing Life-Sustaining Therapy (WLST) within the next 24-48 hours

Contacts and Locations

Study Contact

Leslie Melo, MPH
CONTACT
212-241-3376
leslie.melo@mountsinai.org

Principal Investigator

Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-08
Study Completion Date2025-07

Study Record Updates

Study Start Date2024-07-08
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Delirium
  • Sedation
  • Agitation