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

Primary Purpose

Critical Illness, Circadian Dysregulation, Delirium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep/Circadian Friendly
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sleep/Circadian Friendly

Usual Care

Arm Description

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.

Usual care within intensive care unit

Outcomes

Primary Outcome Measures

Length of Stay in ICU
Time spent from admission to ICU until transfer/discharge or study cessation
Overall Hospital Length of Stay
Total time spent from admission to ICU until discharge from hospital
Rate of ICU mortality
rate of mortality while admitted to ICU
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.
Hospital Readmission Rate
rate of hospital readmission within 30-days of discharge

Secondary Outcome Measures

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.
Overnight Sound Intensity Levels
sound intensity (decibel) within patient room with be continuously recorded through SDL-600 industrial decibel monitors.
Overnight Light Intensity Exposure
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)
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)
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)
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.

Full Information

First Posted
September 9, 2019
Last Updated
June 14, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04111900
Brief Title
Effect of Sleep on the Recovery of Patients Admitted to the ICU
Official Title
Effect of Sleep on the Recovery of Patients Admitted to the ICU
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Circadian Dysregulation, Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep/Circadian Friendly
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care within intensive care unit
Intervention Type
Behavioral
Intervention Name(s)
Sleep/Circadian Friendly
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Stay in ICU
Description
Time spent from admission to ICU until transfer/discharge or study cessation
Time Frame
through study completion, an average of 3-4 days
Title
Overall Hospital Length of Stay
Description
Total time spent from admission to ICU until discharge from hospital
Time Frame
at study completion, an average of 5-7 days
Title
Rate of ICU mortality
Description
rate of mortality while admitted to ICU
Time Frame
at study completion, up to 30 days
Title
Rate of Delirium
Description
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.
Time Frame
Once daily throughout study, on average 3-4 days
Title
Hospital Readmission Rate
Description
rate of hospital readmission within 30-days of discharge
Time Frame
30 days after discharge
Secondary Outcome Measure Information:
Title
ICU sleep score
Description
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.
Time Frame
daily through study completion, an average of 3-4 days
Title
Overnight Sound Intensity Levels
Description
sound intensity (decibel) within patient room with be continuously recorded through SDL-600 industrial decibel monitors.
Time Frame
through study completion, an average of 3-4 days
Title
Overnight Light Intensity Exposure
Description
amount of light patients are exposed to overnight, measured in lux, will be continuously recorded through specialized medical lux monitors.
Time Frame
through study completion, an average of 3-4 days
Title
Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10)
Description
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.
Time Frame
Study Day 1 and Day 2
Title
Concentration of 6-sulphatoxymelatonin (aMT6s)
Description
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.
Time Frame
Study Day 1 and Day 2
Title
Concentration of Lipopolysaccharide binding protein (LBP)
Description
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.
Time Frame
Study Day 1 and Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garth R Swanson, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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

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