Clinical trial NCT04111900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Circadian Dysregulation
Delirium
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Length of Stay in ICU
timeFrame: through study completion, an average of 3-4 days
measure: Overall Hospital Length of Stay
timeFrame: at study completion, an average of 5-7 days
measure: Rate of ICU mortality
timeFrame: at study completion, up to 30 days
measure: Rate of Delirium
timeFrame: Once daily throughout study, on average 3-4 days
measure: Hospital Readmission Rate
timeFrame: 30 days after discharge
Secondary outcomes:
measure: ICU sleep score
timeFrame: daily through study completion, an average of 3-4 days
measure: Overnight Sound Intensity Levels
timeFrame: through study completion, an average of 3-4 days
measure: Overnight Light Intensity Exposure
timeFrame: through study completion, an average of 3-4 days
measure: Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10)
timeFrame: Study Day 1 and Day 2
measure: Concentration of 6-sulphatoxymelatonin (aMT6s)
timeFrame: Study Day 1 and Day 2
measure: Concentration of Lipopolysaccharide binding protein (LBP)
timeFrame: Study Day 1 and Day 2
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Garth R Swanson, MD
role: PRINCIPAL_INVESTIGATOR
References: