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Clinical Trials/NCT04602988
NCT04602988Active, not recruitingNot Applicable

Continuous, Non-Invasive Monitoring of Mental Status

Massachusetts General Hospital1 site in 1 country350 target enrollmentStarted: August 10, 2020Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eyal Y. Kimchi, M.D.,Ph.D.

Assistant Professor

Massachusetts General Hospital

Study Sites (1)

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