Sleep and Circadian Rhythms in Mechanically Ventilated Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Respiratory Failure
• Intervention / Treatment: Behavioral: Environmental modification

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Environmental modification; Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.	Behavioral: Environmental modification; 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.
No Intervention: Usual care (randomized); 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); Usual care was provided.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of REM Sleep	Occurrence of identifiable rapid eye movement (REM) sleep in each subject.	Average 4 days (patients followed to hospital discharge)
Normal Timing of 6-sulfatoxymelatonin Excretion	The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.	Average 4 days (patients followed to hospital discharge)

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Chicago; The Brain Research Foundation

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Polysomnography; Circadian rhythmicity
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: SleepICU111; 5K23HL088020 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: As this is a pilot study, there are no plans to share IPD.