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Effect of Sleep on the Recovery of Patients Admitted to the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04111900
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE September 9, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE February 27, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • ICU sleep score [ Time Frame: daily through study completion, an average of 3-4 days ]
    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.
  • Overnight Sound Intensity Levels [ Time Frame: through study completion, an average of 3-4 days ]
    sound intensity (decibel) within patient room with be continuously recorded through SDL-600 industrial decibel monitors.
  • Overnight Light Intensity Exposure [ Time Frame: through study completion, an average of 3-4 days ]
    amount of light patients are exposed to overnight, measured in lux, will be continuously recorded through specialized medical lux monitors.
  • Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10) [ Time Frame: Study Day 1 and Day 2 ]
    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.
  • Concentration of 6-sulphatoxymelatonin (aMT6s) [ Time Frame: Study Day 1 and Day 2 ]
    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.
  • Concentration of Lipopolysaccharide binding protein (LBP) [ Time Frame: Study Day 1 and Day 2 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Sleep on the Recovery of Patients Admitted to the ICU
Official Title  ICMJE Effect of Sleep on the Recovery of Patients Admitted to the ICU
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Critical Illness
  • Circadian Dysregulation
  • Delirium
Intervention  ICMJE Behavioral: Sleep/Circadian Friendly
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 Arms  ICMJE
  • Experimental: Sleep/Circadian Friendly
    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.
    Intervention: Behavioral: Sleep/Circadian Friendly
  • No Intervention: Usual Care
    Usual care within intensive care unit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • any adult patient admitted to the MICU with an expected length of stay of at least 3 days

Exclusion Criteria:

  • frequent overnight neurological checks or frequent peripheral vascular checks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Garth R Swanson, MD 312-563-3871
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04111900
Other Study ID Numbers  ICMJE 16111002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Garth R Swanson, MD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP