NCT04602988

Study to Assess and Monitor Brain Activity

Continuous, Non-Invasive Monitoring of Mental Status

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium
• Encephalopathy

Interventions

Type	Name	Description
DEVICE	EEG	EEG monitoring of brain rhythms

Timeline

• Start date: 2020-08-10
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2020-10-26
• Last updated: 2022-08-08

Locations

1 site across 1 country: United States