Clinical Trials Directory

Trials / Terminated

TerminatedNCT03322371

Validation of Frontal EEG to Formal Polysomnography in the ICU

Validation of Frontal Limited Lead Electroencephalography (EEG) to Formal Polysomnography (PSG) in the Intensive Care Unit (ICU)

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
University of Utah · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to compare a 2-lead frontal electroencephalogram recording to a formal polysomnography (PSG) in detecting sleep vs. wake and depth of sleep in both healthy and ICU patients.

Detailed description

Sleep in the intensive care unit (ICU) is poor and not well understood. Formal polysomnography (PSG) is the gold standard measure, but impractical for critical care. The relative influence of environment, illness and interventions on sleep in critically ill patients is therefore essentially unknown. Interventions to improve sleep have been pragmatic and outcomes subjective or indirect, and uninformed. When it is done, formal PSG in critical illness demonstrates fragmented, shortened, interrupted and non-circadian sleep, with environmental noise, light, and frequent physical stimulation causing arousals.

Conditions

Interventions

TypeNameDescription
DEVICE2-lead limited electroencephalography recordingThe EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.

Timeline

Start date
2017-11-06
Primary completion
2020-01-01
Completion
2020-01-01
First posted
2017-10-26
Last updated
2021-06-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03322371. Inclusion in this directory is not an endorsement.