| NCT ID | NCT06718764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-07-08 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06718764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06718764 currently recruiting?
Yes, NCT06718764 is actively recruiting participants. Contact the research team at leslie.melo@mountsinai.org for enrollment information.
Where is the NCT06718764 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06718764 clinical trial?
NCT06718764 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21 at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 100 participants.