DeliriumSIDNCT01280097
Study of Sleep and Delirium in the Intensive Care Unit (ICU)
An observational study of Delirium and Sleep Disorders, Circadian Rhythm, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Delirium, Sleep Disorders, Circadian Rhythm
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Nov 2012
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include elderly patients admitted to the intensive care unit at UCSF.
Who may be able to join
- patients ≥ 45 years of age admitted to the ICU, and remain for at least 24 hours.
Who cannot join
- status post craniotomy,
- moribund state with planned withdrawal of life support,
- severe dementia,
- substantial hearing impairment or inability to understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143-0648
About this study
Official title: Sleep Disruption and ICU Delirium: Delirium Assessment and Monitoring Combined With the Evaluation of Sleep Using the Sedline Brain Function Monitor.
The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.
Read the detailed description
Delirium and sleep disruption are both common in the intensive care unit (ICU). Delirium is a state of acute confusion, experienced especially by older adults admitted to the hospital, with the potential to adversely impact patients' outcome. Of hospitalized patients, the highest rate of delirium occurs in elderly patients in the ICU. Development of ICU delirium is associated with longer ICU and hospital length of stay, significantly higher risk of functional decline, loss of independent living, and increased mortality. Previous studies have focused on describing the clinical manifestations, risk factors and outcomes of ICU delirium; yet, the contribution of sleep timing, as well as its quality and quantity, to the development of delirium, has not previously been rigorously investigated. Sleep disturbance, including changes in sleep patterns and architecture, and decreased quality of sleep are commonly observed in older subjects. In the ICU, environmental factors (such as noise levels and continuous ambient light) and health care practices (such as frequent performance of medical procedures and tests) further contribute to sleep disruption in the critically ill older patients. Additionally, many sedative and analgesic agents potently suppress slow wave sleep. In preliminary data acquired from ICU patients, the investigators have observed that fragmented sleep is prevalent due to frequent arousals and awakenings, and that sleep architecture is altered with an increase in light sleep, and a decrease in restorative slow wave sleep. Despite the common occurrence of both ICU delirium and sleep disruption, it is not known whether sleep disruption increases the risk of developing delirium in the critically ill older patients. In this exploratory study, the investigators propose to test the hypothesis that the severity and duration of sleep disruption is an independent predictor of the onset and duration of ICU delirium in a cohort of older ICU patients. The investigators will measure sleep disruption using continuous processed electroencephalography and measure ICU delirium using a well-validated and reliable standardized instrument. Results from this study will inform the contribution of sleep disruption in the development of ICU delirium in the older critically ill patients.
- Conditions
- Delirium, Sleep Disorders, Circadian Rhythm
- Keywords
- Intensive care unit delirium, Sleep disruption, Sleep hygiene, Early mobilization in the Intensive care unit, Sedative agents and sleep, Circadian rhythm, Cognitive disorder, Electroencephalography (EEG) to measure sleep, Confusion Assessment Method in the Intensive Care Unit, Immune function, REM sleep
- Medical subject headings
- Delirium, Sleep Disorders, Circadian Rhythm, Sleep Hygiene, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort study | Observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU delirium
ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.
Measured: Daily measurement during study
Secondary outcomes (5)
Intensive Care Unit (ICU) length of stay
The day of admission to the ICU until the day of discharge from the ICU.
Measured: Assessed at discharge from ICU
Hospital Length of Stay
This is the persons length of stay in the hospital, from admission date until discharge date.
Measured: Assesses at discharge from hospital
ICU mortality
We will collect data on mortality during the stay in the Intensive Care Unit
Measured: Assessed at discharge from ICU
Hospital mortality
We will assess the mortality during the hospital stay.
Measured: Assessed at discharge from hospital
One year mortality
We will assess mortality at one year from hospital admission.
Measured: Assessed at 1 year from admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Labs
- Responsible party
- Sponsor
- Investigators
- Jacqueline M Leung, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280097
- Sponsor's protocol ID
- 10-02079
- Acronym
- SID
- Status last verified
- Jul 2015
- First submitted
- 18 Jan 2011
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disruption and ICU Delirium: Delirium Assessment and Monitoring Combined With the Evaluation of Sleep Using the Sedline Brain Function Monitor.
- ClinicalTrials.gov ID
- NCT01280097
- Acronym / sponsor ID
- SID / 10-02079
- Conditions
- Delirium, Sleep Disorders, Circadian Rhythm
- Keywords
- Intensive care unit delirium, Sleep disruption, Sleep hygiene, Early mobilization in the Intensive care unit, Sedative agents and sleep, Circadian rhythm, Cognitive disorder, Electroencephalography (EEG) to measure sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Masimo Labs
- Study start
- Dec 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Jan 2011 (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 investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.
Detailed description
Delirium and sleep disruption are both common in the intensive care unit (ICU). Delirium is a state of acute confusion, experienced especially by older adults admitted to the hospital, with the potential to adversely impact patients' outcome. Of hospitalized patients, the highest rate of delirium occurs in elderly patients in the ICU. Development of ICU delirium is associated with longer ICU and hospital length of stay, significantly higher risk of functional decline, loss of independent living, and increased mortality. Previous studies have focused on describing the clinical manifestations, risk factors and outcomes of ICU delirium; yet, the contribution of sleep timing, as well as its quality and quantity, to the development of delirium, has not previously been rigorously investigated. Sleep disturbance, including changes in sleep patterns and architecture, and decreased quality of sleep are commonly observed in older subjects. In the ICU, environmental factors (such as noise levels and continuous ambient light) and health care practices (such as frequent performance of medical procedures and tests) further contribute to sleep disruption in the critically ill older patients. Additionally, many sedative and analgesic agents potently suppress slow wave sleep. In preliminary data acquired from ICU patients, the investigators have observed that fragmented sleep is prevalent due to frequent arousals and awakenings, and that sleep architecture is altered with an increase in light sleep, and a decrease in restorative slow wave sleep. Despite the common occurrence of both ICU delirium and sleep disruption, it is not known whether sleep disruption increases the risk of developing delirium in the critically ill older patients. In this exploratory study, the investigators propose to test the hypothesis that the severity and duration of sleep disruption is an independent predictor of the onset and duration of ICU delirium in a cohort of older ICU patients. The investigators will measure sleep disruption using continuous processed electroencephalography and measure ICU delirium using a well-validated and reliable standardized instrument. Results from this study will inform the contribution of sleep disruption in the development of ICU delirium in the older critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort study | – | –Observational only |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include elderly patients admitted to the intensive care unit at UCSF.
Key inclusion criteria (1 listed)
- patients ≥ 45 years of age admitted to the ICU, and remain for at least 24 hours.
Key exclusion criteria (4 listed)
- status post craniotomy,
- moribund state with planned withdrawal of life support,
- severe dementia,
- substantial hearing impairment or inability to understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU delirium
Time frame: Daily measurement during study
ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.
5 secondary outcomes
Intensive Care Unit (ICU) length of stay
Time frame: Assessed at discharge from ICU
Hospital Length of Stay
Time frame: Assesses at discharge from hospital
ICU mortality
Time frame: Assessed at discharge from ICU
Hospital mortality
Time frame: Assessed at discharge from hospital
One year mortality
Time frame: Assessed at 1 year from admission to hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
Jacqueline M Leung, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Sleep Disorders, Circadian Rhythm, run by University of California, San Francisco 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 4 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: finished, as of the sponsor's last update on 15 Jul 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICU delirium (time frame: Daily measurement during study). 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 15 Jul 2015.