Status:
TERMINATED
Validation of Frontal EEG to Formal Polysomnography in the ICU
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Epitel, Inc.
Conditions:
Sleep Deprivation
Sleep
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 patient...
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 environm...
Eligibility Criteria
Inclusion
- Group 1: Healthy Subjects in Sleep Lab:
- Inclusion Criteria
- Age 18 or older
- Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition
- Exclusion Criteria
- Patient/Legally Authorized Representative declines consent
- Group 2: ICU patient, not sedated, not ventilated
- Inclusion Criteria
- Age 18 or older
- Anticipated to stay in intensive care unit overnight (minimum 8 hours)
- Glasgow Coma Scale score of 13 or great
Exclusion
- Intubated with endotracheal tube
- Sedated (includes sedative drugs such as propofol, Dexmedetomidine, versed infusion above 2mg/hr, ketamine infusion above 0.2 mg/kg/hr).
- Group 3: ICU patient, sedated and ventilated
- Inclusion Criteria:
- Age 18 or older
- Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
- Intubated, sedated, and ventilated
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03322371
Start Date
November 6 2017
End Date
January 1 2020
Last Update
June 8 2021
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132