Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.

Condition or disease	Intervention/treatment	Phase
Critical Illness; Sleep Deprivation; Respiratory Failure; Sleep Disorders, Circadian Rhythm	Behavioral: Sleep and circadian rhythm promotion; Behavioral: Usual care	Not Applicable

Detailed Description:

Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Study Start Date :	January 2011
Actual Primary Completion Date :	December 2016
Actual Study Completion Date :	December 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Sleep promotion protocol; Behavioral: sleep and circadian rhythm promotion including timed light exposure.	Behavioral: Sleep and circadian rhythm promotion; This multifaceted intervention will attempt to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. Supplemental bright lights and eyeshades and noise cancelling headphones may also be employed.
Active Comparator: Usual care; Behavioral: usual care.	Behavioral: Usual care; Usual care.

Outcome Measures

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Primary Outcome Measures :

1. Circadian timing [ Time Frame: Day 3 ]
   The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups.

Secondary Outcome Measures :

1. Normal circadian timing [ Time Frame: Day 3 ]
   The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups.
2. Circadian amplitude [ Time Frame: Day 3 ]
   The amplitude of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.
3. Spectral edge frequency 95% [ Time Frame: Day 2 ]
   The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups.
4. Delirium [ Time Frame: Day 3 ]
   The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age 18 years or older
• Receiving mechanical ventilation and intravenous sedation

Exclusion Criteria:

• Debilitating central nervous system disease or degenerative disorder
• Active seizures
• Persistent coma
• Renal failure requiring dialysis
• Expected to be extubated within 24 hours
• Currently receiving neuromuscular blocker

Contacts and Locations

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Locations

United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Brian Gehlbach

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Brian K Gehlbach, MD	University of Iowa

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Brian Gehlbach, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier:	NCT01284140 History of Changes
Other Study ID Numbers:	201105754; 5K23HL088020 ( U.S. NIH Grant/Contract )
First Posted:	January 26, 2011
Last Update Posted:	February 26, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Brian Gehlbach, University of Iowa:

Critical illness; Sleep; Polysomnography	Respiratory failure; Circadian rhythm; Sedation

Additional relevant MeSH terms:

Respiratory Insufficiency; Critical Illness; Sleep Wake Disorders; Parasomnias; Sleep Deprivation; Sleep Disorders, Circadian Rhythm; Respiration Disorders; Respiratory Tract Diseases; Disease Attributes	Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Dyssomnias; Chronobiology Disorders; Occupational Diseases