Sleep and Circadian Rhythms in Mechanically Ventilated Patients

University of Iowa25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Respiratory Failure Critical Illness

Interventions

Environmental modificationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Average 4 days (patients followed to hospital discharge)

Secondary Outcomes

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.

Time frame: Average 4 days (patients followed to hospital discharge)

Data from ClinicalTrials.gov

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