Sleep FragmentationSDPPNCUNCT02997839
Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit
A study testing sleep disruption in people with Sleep Fragmentation, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Fragmentation
- What is being tested?
- sleep disruption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 26 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- post operative back patients in the NCCU with no history of brain injury
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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).
- Conditions
- Sleep Fragmentation
- Being tested
- sleep disruption
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep disruptionBehavioural
Also called group 2
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.
| Study group | Role | What they receive |
|---|---|---|
| group 2 | No intervention | no intervention |
| group 1 | Other | sleep disruption Receives: Behavioral: sleep disruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 hours
Secondary outcomes (3)
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.
Measured: Up to 4 hours
Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire
Measured: Up to 12 hours
Quantitative assessment of alertness using a psychomotor vigilance task (PVT).
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Why it stopped: Change in design to observational study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep FragmentationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul A Nyquist, MD, Principal investigator, Johns Hopkins school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997839
- Sponsor's protocol ID
- IRB00092868
- Acronym
- SDPPNCU
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit
- ClinicalTrials.gov ID
- NCT02997839
- Acronym / sponsor ID
- SDPPNCU / IRB00092868
- Conditions
- Sleep Fragmentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in design to observational study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 2 | No intervention | –no intervention |
| group 1 | Other | Behavioral: sleep disruptionsleep disruption |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post operative back patients in the NCCU with no history of brain injury
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep disruptionAlso: group 2Group 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. | Behavioural | group 1 |
Primary outcome
Detect the effects of disrupted sleep with quantitative EEG analysis
Time frame: Up to 12 hours
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.
3 secondary outcomes
Precision, accuracy and bias of the automated cEEG algorithm by comparing it to the interpretations of sleep trained neurologists
Time frame: Up to 4 hours
Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire
Time frame: Up to 12 hours
Quantitative assessment of alertness using a psychomotor vigilance task (PVT).
Time frame: Up to 12 hours
Results and safety
The study was stopped early (reason given: Change in design to observational study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Nyquist, MD principal investigator
Johns Hopkins school of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep disruption in people with Sleep Fragmentation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in design to observational study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the effects of disrupted sleep with quantitative EEG analysis (time frame: Up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.