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Study to Assess and Monitor Brain Activity

Continuous, Non-Invasive Monitoring of Mental Status

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04602988
Acronym
SAMBA
Enrollment
350
Registered
2020-10-26
Start date
2020-08-10
Completion date
2025-08-31
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Encephalopathy

Keywords

EEG, Mental Status

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.

Interventions

DEVICEEEG

EEG monitoring of brain rhythms

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Delirium SeverityDaily during the time of EEG recording up to 7 daysInpatient Delirium as assessed by the 3D-CAM-S
EEGDaily during the time of EEG recording up to 7 daysRelative EEG power in the delta & theta bands

Secondary

MeasureTime frameDescription
Functional status3 months after completion of EEG recordingFunctional status as assessed by the Glasgow Outcome Score (1-5, with lower numbers less favorable outcomes and higher numbers more favorable outcomes)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026