Clinical trial NCT01276652: Sleep and Circadian Rhythms in Mechanically Ventilated Patients
Official title: Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Critical Illness
Keywords: Polysomnography
Circadian rhythmicity
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: The Brain Research Foundation
name: University of Chicago
First posted: 2011-01-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.
timeFrame: Average 4 days (patients followed to hospital discharge)
Secondary outcomes:
measure: Subject Tolerance of the Environmental Modification Protocol
timeFrame: Average 4 days (patients followed to hospital discharge)
Other outcomes:
measure: Occurrence of REM Sleep
timeFrame: Average 4 days (patients followed to hospital discharge)
measure: Normal Timing of 6-sulfatoxymelatonin Excretion
timeFrame: Average 4 days (patients followed to hospital discharge)
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Brian K Gehlbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Jesse Hall, MD
role: PRINCIPAL_INVESTIGATOR
References: