Continuous, Non-Invasive Monitoring of Mental Status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- EEG
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
EEG
Time Frame: Daily during the time of EEG recording up to 7 days
Relative EEG power in the delta \& theta bands
Delirium Severity
Time Frame: Daily during the time of EEG recording up to 7 days
Inpatient Delirium as assessed by the 3D-CAM-S
Secondary Outcomes
- Functional status(3 months after completion of EEG recording)
Investigators
Eyal Y. Kimchi, M.D.,Ph.D.
Assistant Professor
Massachusetts General Hospital
