Critical IllnessNCT04111900
Effect of Sleep on the Recovery of Patients Admitted to the ICU
A study testing Sleep/Circadian Friendly in people with Critical Illness and Circadian Dysregulation, run by Rush University Medical Center at 1 site in United States.
Trial summary
The investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critical Illness, Circadian Dysregulation, Delirium
- What is being tested?
- Sleep/Circadian Friendly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 31 Jan 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any adult patient admitted to the MICU with an expected length of stay of at least 3 days
Who cannot join
- frequent overnight neurological checks or frequent peripheral vascular checks
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU.
Read the detailed description
Critically ill patients are known to suffer from severely fragmented sleep with a predominance of stage I sleep and a paucity of slow wave and REM sleep. The causes of this sleep disruption include the intensive care unit (ICU) environment, medical illness, psychological stress, and many of the medications and other treatments used to help those who are critically ill. Surveys have identified poor sleep as one of the most frequent complaints among patients who have survived a critical illness. Patients in medical, cardiac, and surgical ICUs almost uniformly have fragmented sleep.
Although illness, pain, and medications contribute to sleep disruption in ICU patients, the primary factor causing sleep disruption had been thought to be the ICU environment. Noise from various sources, including ventilators, alarms, television, phones, beepers, and conversation, have all been purported to disturb sleep in the ICU. Patients have reported that noise, specifically talking, is a frequent cause of sleep disruption in the ICU. Several studies have confirmed that peak noise levels in ICUs are far in excess of 45 dB during the day and 35 dB at night, which are the recommendations of the Environmental Protection Agency for peak noise levels in the ICU.
The clinical importance of this type of sleep disruption in critically ill patients, however, is not known. The investigators hope to determine if placing patients in sleep/circadian rhythm friendly rooms will enable them to achieve better sleep, suffer from decreased delirium, and have improved recovery from their critical illness.
- Conditions
- Critical Illness, Circadian Dysregulation, Delirium
- Being tested
- Sleep/Circadian Friendly
- Medical subject headings
- Critical Illness, Chronobiology Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep/Circadian FriendlyBehavioural
This intervention attempts to improve sleep and prevent circadian rhythm dysregulation among patients admitted to the medical intensive care unit (MICU). Patients within his arm will be asked to try to keep their TV off and limit their telephone use from 10pm-7am, as well as limit the amount of visitors in their room as much as possible between those hours. Patients will also be offered ear plugs and eye masks if they wish to use at night to aid in helping them sleep, if deemed medically safe to do so. Additionally nurses will be asked to bathe patients either before 10pm or after 7am, to limit their conversations in the patient's room at night, and try as much as possible to limit blood draws and waking patients during those hours as is medically safe. Nurses will also be instructed to lower the blinds in the room at 10 pm and raise them up at 7am to help with patients sleep/wake cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sleep/Circadian Friendly | Experimental | initiation of sleep/circadian rhythm friendly intervention the first night spent in MICU after enrollment until patient transfers/discharges, ceases participation, or meets exclusion criteria. Receives: Behavioral: Sleep/Circadian Friendly |
| Usual Care | No intervention | Usual care within intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in ICU
Time spent from admission to ICU until transfer/discharge or study cessation
Measured: through study completion, an average of 3-4 days
Overall Hospital Length of Stay
Total time spent from admission to ICU until discharge from hospital
Measured: at study completion, an average of 5-7 days
Rate of ICU mortality
rate of mortality while admitted to ICU
Measured: at study completion, up to 30 days
Rate of Delirium
Assess development of delirium through administration of CAM-ICU and RASS performed daily by nursing staff per routine care. Delirium will be considered present if CAM-ICU is positive or RASS above +1 or below -1 at anytime during study.
Measured: Once daily throughout study, on average 3-4 days
Hospital Readmission Rate
rate of hospital readmission within 30-days of discharge
Measured: 30 days after discharge
Secondary outcomes (6)
ICU sleep score
Assess sleep quality through administration of Richard Campbell Sleep Questionnaire (RCSQ). RCSQ is a simple and validated survey to measure sleep quality in ICU settings. RCSQ consists of a series of 8 patient reported questions covering sleep depth, sleep latency, total amount of sleep, number of awakenings, sleep quality, noise rating, light rating, and sleep quality compared to at home. All questions are to be reported on a scale of 0-100 with higher values corresponding to better sleep values.
Measured: daily through study completion, an average of 3-4 days
Overnight Sound Intensity Levels
sound intensity (decibel) within patient room with be continuously recorded through SDL-600 industrial decibel monitors.
Measured: through study completion, an average of 3-4 days
Overnight Light Intensity Exposure
amount of light patients are exposed to overnight, measured in lux, will be continuously recorded through specialized medical lux monitors.
Measured: through study completion, an average of 3-4 days
Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10)
concentrations of IL-6 (pg/mL) and IL-10 (pg/mL), inflammatory cytokines found to play a role in circadian regulation, levels will be measured from approximately 2mL of plasma that will be collected concurrently during morning routine care lab draw.
Measured: Study Day 1 and Day 2
Concentration of 6-sulphatoxymelatonin (aMT6s)
concentrations of 6-sulphatoxymelatonin (pg/mL), the primary urine metabolite of melatonin and circadian rhythm phase marker, will be measured from left-over voided urine collected from patients prior to discard.
Measured: Study Day 1 and Day 2
Concentration of Lipopolysaccharide binding protein (LBP)
Levels of LBP (pg/mL), an acute phase protein that upregulates during an inflammatory physiologic state, will be measured from 2mL of blood taken concurrently with routine morning labs.
Measured: Study Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start27 Feb 2017
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garth R Swanson, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111900
- Sponsor's protocol ID
- 16111002
- Status last verified
- Jun 2023
- First submitted
- 9 Sep 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep on the Recovery of Patients Admitted to the ICU
- ClinicalTrials.gov ID
- NCT04111900
- Acronym / sponsor ID
- 16111002
- Conditions
- Critical Illness, Circadian Dysregulation, Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Oct 2019 (actual)
- 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 plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU.
Detailed description
Critically ill patients are known to suffer from severely fragmented sleep with a predominance of stage I sleep and a paucity of slow wave and REM sleep. The causes of this sleep disruption include the intensive care unit (ICU) environment, medical illness, psychological stress, and many of the medications and other treatments used to help those who are critically ill. Surveys have identified poor sleep as one of the most frequent complaints among patients who have survived a critical illness. Patients in medical, cardiac, and surgical ICUs almost uniformly have fragmented sleep.
Although illness, pain, and medications contribute to sleep disruption in ICU patients, the primary factor causing sleep disruption had been thought to be the ICU environment. Noise from various sources, including ventilators, alarms, television, phones, beepers, and conversation, have all been purported to disturb sleep in the ICU. Patients have reported that noise, specifically talking, is a frequent cause of sleep disruption in the ICU. Several studies have confirmed that peak noise levels in ICUs are far in excess of 45 dB during the day and 35 dB at night, which are the recommendations of the Environmental Protection Agency for peak noise levels in the ICU.
The clinical importance of this type of sleep disruption in critically ill patients, however, is not known. The investigators hope to determine if placing patients in sleep/circadian rhythm friendly rooms will enable them to achieve better sleep, suffer from decreased delirium, and have improved recovery from their critical illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep/Circadian Friendly | Experimental | Behavioral: Sleep/Circadian Friendlyinitiation of sleep/circadian rhythm friendly intervention the first night spent in MICU after enrollment until patient transfers/discharges, ceases participation, or meets exclusion criteria. |
| Usual Care | No intervention | –Usual care within intensive care unit |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any adult patient admitted to the MICU with an expected length of stay of at least 3 days
Key exclusion criteria (1 listed)
- frequent overnight neurological checks or frequent peripheral vascular checks
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/Circadian FriendlyThis intervention attempts to improve sleep and prevent circadian rhythm dysregulation among patients admitted to the medical intensive care unit (MICU). Patients within his arm will be asked to try to keep their TV off and limit their telephone use from 10pm-7am, as well as limit the amount of visitors in their room as much as possible between those hours. Patients will also be offered ear plugs and eye masks if they wish to use at night to aid in helping them sleep, if deemed medically safe to do so. Additionally nurses will be asked to bathe patients either before 10pm or after 7am, to limit their conversations in the patient's room at night, and try as much as possible to limit blood draws and waking patients during those hours as is medically safe. Nurses will also be instructed to lower the blinds in the room at 10 pm and raise them up at 7am to help with patients sleep/wake cycle. | Behavioural | Sleep/Circadian Friendly |
Primary outcome
Length of Stay in ICU
Time frame: through study completion, an average of 3-4 days
Time spent from admission to ICU until transfer/discharge or study cessation
Overall Hospital Length of Stay
Time frame: at study completion, an average of 5-7 days
Total time spent from admission to ICU until discharge from hospital
Rate of ICU mortality
Time frame: at study completion, up to 30 days
rate of mortality while admitted to ICU
Rate of Delirium
Time frame: Once daily throughout study, on average 3-4 days
Assess development of delirium through administration of CAM-ICU and RASS performed daily by nursing staff per routine care. Delirium will be considered present if CAM-ICU is positive or RASS above +1 or below -1 at anytime during study.
Hospital Readmission Rate
Time frame: 30 days after discharge
rate of hospital readmission within 30-days of discharge
6 secondary outcomes
ICU sleep score
Time frame: daily through study completion, an average of 3-4 days
Overnight Sound Intensity Levels
Time frame: through study completion, an average of 3-4 days
Overnight Light Intensity Exposure
Time frame: through study completion, an average of 3-4 days
Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10)
Time frame: Study Day 1 and Day 2
Concentration of 6-sulphatoxymelatonin (aMT6s)
Time frame: Study Day 1 and Day 2
Concentration of Lipopolysaccharide binding protein (LBP)
Time frame: Study Day 1 and Day 2
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 18 Jun 2023.
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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.
Garth R Swanson, MD principal investigator
Rush University Medical Center
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/Circadian Friendly in people with Critical Illness and Circadian Dysregulation, run by Rush University Medical Center 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: finished, as of the sponsor's last update on 18 Jun 2023. 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?
Length of Stay in ICU (time frame: through study completion, an average of 3-4 days). The study lists 5 primary outcomes in all. 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 18 Jun 2023.