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Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brian Gehlbach, University of Iowa
ClinicalTrials.gov Identifier:
NCT01284140
First received: January 19, 2011
Last updated: December 21, 2011
Last verified: December 2011
  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:


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: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep promotion protocol 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 will also be employed.
Active Comparator: 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
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

Contacts
Contact: Brian K Gehlbach, MD 319-356-3603 brian-gehlbach@uiowa.edu
Contact: Andy Potts, RN 319-384-5376 andrew-potts@uiowa.edu

Locations
United States, Illinois
University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Brian K Gehlbach, MD    319-356-3603    brian-gehlbach@uiowa.edu   
Contact: Andy Potts, RN    319-384-5376    andrew-potts@uiowa.edu   
Principal Investigator: Brian K Gehlbach, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Brian K Gehlbach, MD University of Iowa
  More Information

No publications provided

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: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Critical illness
Sleep
Polysomnography
Respiratory failure
Circadian rhythm
Sedation

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

ClinicalTrials.gov processed this record on November 24, 2014