Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

Not Applicable

Completed

Conditions: Sleep Deprivation
Sleep Disorders, Circadian Rhythm
Critical Illness
Respiratory Failure

Interventions: Behavioral: Usual care
Behavioral: Sleep and circadian rhythm promotion

Brief Summary: The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.

Detailed Description: Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Behavioral: 48 hours of usual care.
Sleep promotion protocol	Sleep and circadian rhythm promotion	Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.

Primary Outcome Measures

Name	Time	Method
Circadian Timing	Day 1 to Day 3	The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1).

Secondary Outcome Measures

Name	Time	Method
Normal Circadian Timing	Day 3	The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups.
Circadian Amplitude	Day 3	The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.
Delirium	Day 3	The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups.
Spectral Edge Frequency 95%	Day 2	The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups.

Locations (2): University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States