Sleep, Sleep Deprivation
Conditions
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 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.
Interventions
DEVICE2-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.
Sponsors
Epitel, Inc.
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Stage Correlation | Overnight (with a minimum of 960 epochs) | The correlation of each sleep stage (Wake, NREM1, NREM2, NREM3, REM) as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep vs Wake Correlation | Overnight (with a minimum of 960 epochs) | The correlation of sleep (NREM1, NREM2, NREM3, REM) vs wake as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sound and Light during Sleep | Overnight (with a minimum of 960 epochs) | The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with sound and light levels within the ICU. |
| Environmental Conditions during Sleep | Overnight (with a minimum of 960 epochs) | The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with environmental conditions within the ICU. |
Countries
United States
Outcome results
None listed