Sleep and Circadian Rhythms in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.

Detailed Description
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Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.

Official Title
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Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.

Conditions
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Respiratory Failure, Critical Illness

Intervention / Treatment
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* Behavioral: Environmental modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults undergoing mechanical ventilation in the medical intensive care unit. Exclusion Criteria: Central nervous system disease (stroke, seizure, dementia, etc) Metabolic or hypoxic encephalopathy Confirmed or suspected drug overdose Currently receiving neuromuscular blockers Coma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Environmental modification<br>Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment. | Behavioral: Environmental modification<br>* Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.<br>|
| No Intervention: Usual care (randomized)<br>Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the Delayed intervention was later removed from the protocol. | |
| No Intervention: Usual care (observational)<br>Usual care was provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours. | This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography. | Average 4 days (patients followed to hospital discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Tolerance of the Environmental Modification Protocol | This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects. | Average 4 days (patients followed to hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polysomnography, Circadian rhythmicity