Study to Assess and Monitor Brain Activity

Delirium Clinical Trial

— SAMBA  

Official title:

Continuous, Non-Invasive Monitoring of Mental Status

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04602988
• Other study ID #: 2020P000678
• Status: Active, not recruiting
• Start date: August 10, 2020
• Est. completion date: August 2025

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Delirium
• Encephalopathy

Intervention

Device:
• EEG
EEG monitoring of brain rhythms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium Severity	Inpatient Delirium as assessed by the 3D-CAM-S	Daily during the time of EEG recording up to 7 days
Primary	EEG	Relative EEG power in the delta & theta bands	Daily during the time of EEG recording up to 7 days
Secondary	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