Study to Assess and Monitor Brain Activity

Study Overview
=================
Brief Summary
-----------------
A mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. Changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. Patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. Delirium remains under-recognized in the hospital, in part due to its fluctuating nature. Typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. As such, there is a clear clinical need for objective, continuous methods to monitor mental status. Such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. In this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of EEG.

Official Title
-----------------
Continuous, Non-Invasive Monitoring of Mental Status

Conditions
-----------------
Delirium, Encephalopathy

Intervention / Treatment
-----------------
* Device: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to a general medical ward Expected stay of at least one night Exclusion Criteria: patients who have any scalp incisions or head wound(s) that would prevent EEG attachment Non-English speakers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients admitted to an inpatient hospital unit<br>Patients admitted to an inpatient hospital unit will receive EEG based monitoring of mental status | Device: EEG<br>* EEG monitoring of brain rhythms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium Severity | Inpatient Delirium as assessed by the 3D-CAM-S | Daily during the time of EEG recording up to 7 days | 
| EEG | Relative EEG power in the delta & theta bands | Daily during the time of EEG recording up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | Functional status as assessed by the Glasgow Outcome Score (1-5, with lower numbers less favorable outcomes and higher numbers more favorable outcomes) | 3 months after completion of EEG recording | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, Mental Status