Trials / Terminated
TerminatedNCT03322371
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)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-11-06
- Primary completion
- 2020-01-01
- Completion
- 2020-01-01
- First posted
- 2017-10-26
- Last updated
- 2021-06-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03322371. Inclusion in this directory is not an endorsement.