Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Brian Gehlbach, University of Iowa
ClinicalTrials.gov Identifier:
NCT01284140
First received: January 19, 2011
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
  Purpose
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 Intervention Phase
Critical Illness
Sleep Deprivation
Respiratory Failure
Sleep Disorders, Circadian Rhythm
 Behavioral: Sleep and circadian rhythm promotion
Behavioral: Usual care
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Circadian timing [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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:
  • Normal circadian timing [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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.

  • Circadian amplitude [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    The amplitude of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.

  • Spectral edge frequency 95% [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    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.

  • Delirium [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups.
Estimated Enrollment: 58
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Iowa
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Brian K Gehlbach, MD University of Iowa
  More Information

Responsible Party: Brian Gehlbach, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01284140     History of Changes
Other Study ID Numbers: 11162B  5K23HL088020 
Study First Received: January 19, 2011
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016