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Completed

NCT Number: NCT01276652

Sleep and Circadian Rhythms in Mechanically Ventilated Patients

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.

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Key information

Conditions

Respiratory Failure Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Environmental modification

Behavioral

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.

Primary outcomes

  1. Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.

    Time frame: 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 outcomes

  1. Subject Tolerance of the Environmental Modification Protocol

    Time frame: 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.

Other outcomes

  1. Occurrence of REM Sleep

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

    Occurrence of identifiable rapid eye movement (REM) sleep in each subject.

  2. Normal Timing of 6-sulfatoxymelatonin Excretion

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

    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.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • The Brain Research Foundation
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Jan 13, 2011
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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