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

Not Applicable

Completed

• Conditions: Circadian Dysregulation; Critical Illness; Delirium
• Interventions: Behavioral: Sleep/Circadian Friendly

• Registration Number: NCT04111900
• Lead Sponsor: Rush University Medical Center

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 Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep/Circadian Friendly	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.

Primary Outcome Measures

Name	Time	Method
Rate of ICU mortality	at study completion, up to 30 days	rate of mortality while admitted to ICU
Rate of Delirium	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.
Length of Stay in ICU	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	at study completion, an average of 5-7 days	Total time spent from admission to ICU until discharge from hospital
Hospital Readmission Rate	30 days after discharge	rate of hospital readmission within 30-days of discharge

Secondary Outcome Measures

Name	Time	Method
ICU sleep score	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	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	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)	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)	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)	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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States