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Completed

NCT Number: NCT04111900

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

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.

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Key information

Conditions

Critical Illness Chronobiology Disorders Circadian Dysregulation Confusion Delirium Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep/Circadian Friendly

Behavioral

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 outcomes

  1. 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

  2. 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

  3. Rate of ICU mortality

    Time frame: at study completion, up to 30 days

    rate of mortality while admitted to ICU

  4. 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.

  5. Hospital Readmission Rate

    Time frame: 30 days after discharge

    rate of hospital readmission within 30-days of discharge

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 1, 2019
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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