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)

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.

Study Overview

• Status: Terminated
• Conditions: Sleep; Sleep Deprivation
• Intervention / Treatment: Device: 2-lead limited electroencephalography recording

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Criteria:

• 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

Exclusion Criteria:

• Presence of traumatic brain injury
• Planned extubation in next 8 hours
• Scheduled to leave the intensive care unit for any reason in the next 8 hours
• Anticipated life expectancy of less than 24 hours
• Electroencephalogram monitoring (current or scheduled in the next 8 hours)
• Hemodynamic instability (defined as: (i) mean arterial pressure <60mmHg for >20 minutes with efforts to raise it or (ii) >2 liter fluid administered in 2h after operating room and anticipating on-going needs for fluid resuscitation or (iii) ICU MD determination of "atypical and profound hemodynamic instability" or (iv) PI determination after evaluation.
• Refractory hypoxemia - defined as Saturation <88% on Sp02 despite efforts to increase it
• Hemorrhage - defined as >500cc chest tube output in 2h and anticipated need of more than 2 units of packed red blood cells in immediate post op period. This does NOT include cell-saver.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Health Subjects in Sleep Lab; Adult patients (> 18yrs old) scheduled for a standard of care PSG (sleep study) lasting at least 8 hours for any condition. Patients will undergo simultaneous 2-lead limited EEG recording with experimental device. 2-lead limited electroencephalography recording	Device: 2-lead limited electroencephalography recording; The 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.; Other Names: Health Subjects in Sleep Lab; ICU patients, not sedated or ventilated; ICU patient, sedated and ventilated
Other: ICU patients, not sedated or ventilated; Adult ICU patients (> 18yrs old) anticipated to stay in the ICU overnight (minimum 8 hours) with a Glasgow Coma Scale of 13 or greater, not intubated and not sedated. Patients will undergo simultaneous 2-lead limited electroencephalography recording	Device: 2-lead limited electroencephalography recording; The 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.; Other Names: Health Subjects in Sleep Lab; ICU patients, not sedated or ventilated; ICU patient, sedated and ventilated
Other: ICU patients, sedated and ventilated; Adult ICU patients (> 18yrs old) who are intubated, sedated, ventilated, and anticipated to stay in the ICU overnight (minimum 8 hours). Patients will undergo simultaneous 2-lead limited electroencephalography recording	Device: 2-lead limited electroencephalography recording; The 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.; Other Names: Health Subjects in Sleep Lab; ICU patients, not sedated or ventilated; ICU patient, sedated and ventilated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Stage Correlation	The correlation of each sleep stage (Wake, NREM1, NREM2, NREM3, REM) as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)	Overnight (with a minimum of 960 epochs)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep vs Wake Correlation	The correlation of sleep (NREM1, NREM2, NREM3, REM) vs wake as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)	Overnight (with a minimum of 960 epochs)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound and Light during Sleep	The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with sound and light levels within the ICU.	Overnight (with a minimum of 960 epochs)
Environmental Conditions during Sleep	The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with environmental conditions within the ICU.	Overnight (with a minimum of 960 epochs)

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Epitel, Inc.
• Investigators: Principal Investigator: Joseph Tonna, MD, FAAEM, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: 87693

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No