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Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit (SDPPNCU)

Primary Purpose

Sleep Fragmentation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sleep disruption
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Fragmentation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • post operative back patients in the NCCU with no history of brain injury

Exclusion Criteria:

  • None

Sites / Locations

  • Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

group 2

group 1

Arm Description

no intervention

sleep disruption

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire
Quantitative assessment of alertness using a psychomotor vigilance task (PVT).

Full Information

First Posted
December 16, 2016
Last Updated
April 2, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02997839
Brief Title
Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit
Acronym
SDPPNCU
Official Title
Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Change in design to observational study
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The importance of sleep for patients in the intensive care unit (ICU) has been well documented. Research has shown that the ICU has multiple risk factors for poor sleep, and that this has multiple effects on patient outcomes. Further research is needed to better define the best tool to use for measuring sleep stages in ICU patients. Furthermore, there is very limited data comparing sleep interruption in ICU patients and the effects on sleep architecture and cognition. Hypothesis 1a: The number of episodes of rapid eye movements (REM), stage 1, stage 2, stage 3 sleep, sleep spindles, and alpha activity will increase while the total duration of activity and the duration of episodes will decline in the postoperative neurologic critical care unit (NCCU) with neurological checks every two hours over a 12 hour period of recording as compared to every 6 hours. Hypothesis 1b: As the number of episodes of REM, stage 1, stage 2, stage 3 sleep, sleep spindles, and alpha activity increase while the total duration of activity and the duration of episodes decline in the postoperative NCCU with neurological checks every two hours over a 12 hour period of recording as compared to every 6 hours. Hypothesis 2: The number of episodes, the total duration, and the interval durations, of REM, stage 1, stage 2, stage 3 sleep, sleep spindles, and alpha activity will be identical in the automated recordings as compared to human reading by a sleep trained Neurologist. Hypothesis 3: The group with awakenings every two hours will report more objective sleepiness and perform psychomotor visual task (PVT) with increased time and reduced performance. Performing this study will allow for validation of an automated EEG system for the interpretation of sleep. If this tool is a reliable method of sleep interpretation, it may be expanded to a larger population of ICU patients for further research on the effects of sleep deprivation. Additionally, it will add prospective data to the literature regarding the psychomotor effects of increased sleep interruption in ICU patients. 2. Objectives (include all primary and secondary objectives) Detect the effects of disrupted sleep resulting from frequent neurological exams in the NCCU in post-surgical patients. 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. The investigators will study the precision, accuracy and bias of the automated algorithm by comparing it to the interpretations of two sleep trained neurologists who 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. Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire (RCSG). Quantitative assessment of alertness using a psychomotor vigilance task (PVT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Fragmentation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 2
Arm Type
No Intervention
Arm Description
no intervention
Arm Title
group 1
Arm Type
Other
Arm Description
sleep disruption
Intervention Type
Behavioral
Intervention Name(s)
sleep disruption
Other Intervention Name(s)
group 2
Intervention Description
Group two will have interrupted sleep at time periods of 2 hours post operatively. Group two will be woken every 2 hours, which is the standard NCCU protocol.
Primary Outcome Measure Information:
Title
Detect the effects of disrupted sleep with quantitative EEG analysis
Description
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.
Time Frame
Up to 12 hours
Secondary Outcome Measure Information:
Title
Precision, accuracy and bias of the automated cEEG algorithm by comparing it to the interpretations of sleep trained neurologists
Description
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.
Time Frame
Up to 4 hours
Title
Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire
Time Frame
Up to 12 hours
Title
Quantitative assessment of alertness using a psychomotor vigilance task (PVT).
Time Frame
Up to 12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: post operative back patients in the NCCU with no history of brain injury Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Nyquist, MD
Organizational Affiliation
Johns Hopkins school of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit

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