Sleep Fragmentation Clinical Trial
— SDPPNCUOfficial title:
Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit
Verified date | April 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The role of sleep in patients admitted to the intensive care unit is an emerging field of research. There have been studies that show patients in the ICU have poor sleep including sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2, 3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure, and frequent arousals for medical care. Not only does poor sleep contribute to reduced cognitive function and delirium, but there are also implications for the immune system function and wound healing (4). Polysomnography is regarded as the gold standard for sleep studies, however it has limited utility in the ICU population (5) and alternative methods of sleep analysis need to be investigated to better understand the underlying physiologic mechanisms and subsequent cognitive effects.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 26, 2018 |
Est. primary completion date | March 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - post operative back patients in the NCCU with no history of brain injury Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detect the effects of disrupted sleep with quantitative EEG analysis | The investigators will use an automated EEG detection system used in patients with continuous EEG (cEEG) monitoring to detect duration of sleep related EEG brain activity, number of intervals of activation, and the duration of the intervals for sleep activities including: REM, Stage 1, stage 2, and stage 3 sleep, sleep spindles, and alpha activity. | Up to 12 hours | |
Secondary | Precision, accuracy and bias of the automated cEEG algorithm by comparing it to the interpretations of sleep trained neurologists | Two sleep trained neurologists will read these recordings in a blinded manner independently of one another. The investigators will select records to validate the automatic scorer including the identification and duration of all aspects of the cEEG sleep recording during the first four hours of sleep recording for each patient. The investigators will compare the accuracy of identification and measured duration of REM, Stage one, stage two, stage 3 sleep, sleep spindles, and alpha activity. | Up to 4 hours | |
Secondary | Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire | Up to 12 hours | ||
Secondary | Quantitative assessment of alertness using a psychomotor vigilance task (PVT). | Up to 12 hours |
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