Sleep and Circadian Rhythms in Mechanically Ventilated Patients

Not Applicable

Completed

• Conditions: Respiratory Failure; Critical Illness
• Interventions: Behavioral: Environmental modification

• Registration Number: NCT01276652
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Results First Submitted: 2016-12-29
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-25
• Last Update Submitted: 2017-07-25
• Results First Posted: 2017-09-26
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Environmental modification	Environmental modification	Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.	Average 4 days (patients followed to hospital discharge)	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.

Secondary Outcome Measures

Name	Time	Method
Subject Tolerance of the Environmental Modification Protocol	Average 4 days (patients followed to hospital discharge)	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States