DeliriumNCT06718764
Neurosteer Bedside Monitoring System
A study testing Neurosteer's single-channel EEG monitoring device in people with Delirium and Sedation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Neurosteer's single-channel EEG monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21, 212-241-3374, neha.dangayach@mountsinai.org
Leslie Melo, MPH, leslie.melo@mountsinai.org
About this study
Official title: Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
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.
Read the detailed description
In the study population of sedated, intubated critically ill patients, the research team hypothesize the following:
- Neurosteer's derived signals and parameters will be correlated to and will have at least fair agreement with the Richmond Agitation Sedation Scale (RASS) for measuring depth of sedation.
- Neurosteer's derived signals and parameters will be correlated to and have at least fair agreement with the Confusion Assessment Method (CAM-ICU) to screen for and diagnose delirium.
- For enrolled patients undergoing cEEG monitoring as standard of care, the detection of burst suppression, seizures, and ictal-interictal continuum between Neurosteer's derived signals and parameters and continuous EEG monitoring readings will be correlated and have at least fair agreement.
- There will be no significant difference in the correlations determined in our primary objective between NSICU patients with and without ANI.
The research team will be conducting a single-site study to evaluate these hypotheses. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have an ANI and the other 50 will not have an ANI. The research team will define ANI as subjects having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. The research team will define subject without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. The research team will obtain written informed consent from all patients and/or their Legally Authorized Representative (LAR) to conduct the study. All enrolled patients will receive the intervention, the Neurosteer brain monitoring platform. Intra-individual comparisons will be made between standard of care assessments and the findings of the Neurosteer device. Inter-individual comparisons between patients with and without ANI will also be made. Statistical analyses will be conducted halfway through study enrollment and upon completion of enrollment and data entry. The study intervention will span the duration of the patient's admission in the NSICU. Patients will be screened for consented and screened for eligibility as they get admitted to the NSICU.
- Being tested
- Neurosteer's single-channel EEG monitoring device
- Medical subject headings
- Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurosteer's single-channel EEG monitoring deviceDevice
Neurosteer device will be attached to participants forehead and readings will be collected for the duration of their NSICU stay.
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.
| Study group | Role | What they receive |
|---|---|---|
| NSICU Patients with Acute Neurological Injuries (ANI) | Active comparator | ANI are participants having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. All participants will be set up with the Neurosteer bedside monitoring system. Receives: Device: Neurosteer's single-channel EEG monitoring device |
| NSICU Patients without Acute Neurological Injuries (ANI) | Active comparator | Participants without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. All participants will be set up with the Neurosteer bedside monitoring system. Receives: Device: Neurosteer's single-channel EEG monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation as measured by Richmond Agitation Sedation Scale
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
- Awakens to voice (eye opening/contact) >10 sec
- Light sedation, briefly awakens to voice (eye opening/contact) <10 sec
- Moderate sedation, movement or eye opening. No eye contact
- Deep sedation, no response to voice, but movement or eye opening to physical stimulation
- Unarousable, no response to voice or physical stimulation
Measured: 3-4 times daily throughout participants NSICU stay (average 14 days)
Secondary outcomes (1)
Delirium as measured by Confusion Assessment Method (CAM)
Confusion Assessment Method (CAM) for screening and diagnosing delirium in intubated, sedated critically ill patients. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Measured: 1-2 times daily throughout participants NSICU stay (average 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start8 Jul 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Neurosteer Ltd.
- Responsible party
- Principal investigator, Neha Dangayach, Icahn School of Medicine at Mount Sinai
- Investigators
- Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718764
- Sponsor's protocol ID
- STUDY-23-00018
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The research team will only share aggregated, de-identified data with the sponsor solely for the purpose of analyzing correlations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06718764
- Acronym / sponsor ID
- STUDY-23-00018
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Neurosteer Ltd.
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the study population of sedated, intubated critically ill patients, the research team hypothesize the following:
- Neurosteer's derived signals and parameters will be correlated to and will have at least fair agreement with the Richmond Agitation Sedation Scale (RASS) for measuring depth of sedation.
- Neurosteer's derived signals and parameters will be correlated to and have at least fair agreement with the Confusion Assessment Method (CAM-ICU) to screen for and diagnose delirium.
- For enrolled patients undergoing cEEG monitoring as standard of care, the detection of burst suppression, seizures, and ictal-interictal continuum between Neurosteer's derived signals and parameters and continuous EEG monitoring readings will be correlated and have at least fair agreement.
- There will be no significant difference in the correlations determined in our primary objective between NSICU patients with and without ANI.
The research team will be conducting a single-site study to evaluate these hypotheses. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have an ANI and the other 50 will not have an ANI. The research team will define ANI as subjects having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. The research team will define subject without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. The research team will obtain written informed consent from all patients and/or their Legally Authorized Representative (LAR) to conduct the study. All enrolled patients will receive the intervention, the Neurosteer brain monitoring platform. Intra-individual comparisons will be made between standard of care assessments and the findings of the Neurosteer device. Inter-individual comparisons between patients with and without ANI will also be made. Statistical analyses will be conducted halfway through study enrollment and upon completion of enrollment and data entry. The study intervention will span the duration of the patient's admission in the NSICU. Patients will be screened for consented and screened for eligibility as they get admitted to the NSICU.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSICU Patients with Acute Neurological Injuries (ANI) | Active comparator | Device: Neurosteer's single-channel EEG monitoring deviceANI are participants having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. All participants will be set up with the Neurosteer bedside monitoring system. |
| NSICU Patients without Acute Neurological Injuries (ANI) | Active comparator | Device: Neurosteer's single-channel EEG monitoring deviceParticipants without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. All participants will be set up with the Neurosteer bedside monitoring system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurosteer's single-channel EEG monitoring deviceNeurosteer device will be attached to participants forehead and readings will be collected for the duration of their NSICU stay. 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. | Device | NSICU Patients with Acute Neurological Injuries (ANI), NSICU Patients without Acute Neurological Injuries (ANI) |
Primary outcome
Sedation as measured by Richmond Agitation Sedation Scale
Time frame: 3-4 times daily throughout participants NSICU stay (average 14 days)
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. Awakens to voice (eye opening/contact) >10 sec 2. Light sedation, briefly awakens to voice (eye opening/contact) <10 sec 3. Moderate sedation, movement or eye opening. No eye contact 4. Deep sedation, no response to voice, but movement or eye opening to physical stimulation 5. Unarousable, no response to voice or physical stimulation
1 secondary outcome
Delirium as measured by Confusion Assessment Method (CAM)
Time frame: 1-2 times daily throughout participants NSICU stay (average 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. The research team will only share aggregated, de-identified data with the sponsor solely for the purpose of analyzing correlations.
Related trials for Delirium
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
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Prediction and Prevention of Postoperative Mortality and Morbidity
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Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21 principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurosteer's single-channel EEG monitoring device in people with Delirium and Sedation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie Melo, MPH (212-241-3376, leslie.melo@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation as measured by Richmond Agitation Sedation Scale (time frame: 3-4 times daily throughout participants NSICU stay (average 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.