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Difficulty analyzing PSG data
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| Name | Class |
|---|---|
| Epitel, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Subjects in Sleep Lab | Other | 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 |
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| ICU patients, not sedated or ventilated | Other | 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 |
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| ICU patients, sedated and ventilated | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-lead limited electroencephalography recording | Device | 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. |
| 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) |
| 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) |
| 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 |
Group 1: Healthy Subjects in Sleep Lab:
Inclusion Criteria
Exclusion Criteria
Group 2: ICU patient, not sedated, not ventilated
Inclusion Criteria
Exclusion Criteria:
Group 3: ICU patient, sedated and ventilated
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Tonna, MD, FAAEM | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with environmental conditions within the ICU.
| Overnight (with a minimum of 960 epochs) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |