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Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT01284140
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Brian Gehlbach, University of Iowa

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 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

Arm Intervention/treatment
Experimental: Sleep promotion protocol
Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.
Behavioral: Sleep and circadian rhythm promotion
This multifaceted intervention attempts 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. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study.
Active Comparator: Usual care
Behavioral: 48 hours of usual care.
Behavioral: Usual care
Usual care.



Primary Outcome Measures :
  1. Circadian Timing [ Time Frame: Day 1 to 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. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1).


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 (e.g. one half the value from peak to trough of the fitted cosine curve) 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284140


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

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    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018
Last Verified: May 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:
Sleep Disorders, Circadian Rhythm
Respiratory Insufficiency
Critical Illness
Sleep Wake Disorders
Parasomnias
Sleep Deprivation
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Dyssomnias
Chronobiology Disorders
Occupational Diseases