Validation of Frontal EEG to Formal Polysomnography in the ICU

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Deprivation, Sleep

Intervention / Treatment
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* Device: 2-lead limited electroencephalography recording


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health Subjects in Sleep Lab<br>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<br>* 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.<br>* Other names: ICU patient, sedated and ventilated;|
| Other: ICU patients, not sedated or ventilated<br>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<br>* 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.<br>* Other names: ICU patient, sedated and ventilated;|
| Other: ICU patients, sedated and ventilated<br>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<br>* 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.<br>* Other names: ICU patient, sedated and ventilated;|

What is the study measuring?
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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) |