Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

ID: NCT01284140
Status: Completed
Phase: N/A
Start Date: January 01, 2011
First Submitted: January 19, 2011
Last Updated: February 23, 2018
Results: N/A
Organization: University of Iowa
Sponsors & Collaborators: Brian Gehlbach, National Heart, Lung, and Blood Institute (NHLBI)
Location: United States
Conditions: Critical Illness, Sleep Deprivation, Respiratory Failure, Sleep Disorders, Circadian Rhythm
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Critical Illness

Respiratory Failure

Sleep Deprivation

Sleep Disorders, Circadian Rhythm

Behavioral: Sleep and circadian rhythm promotion
Other Names
Behavioral: Usual care
Other Names
N/A

Tracking Information

First Submitted DateJanuary 19, 2011
Last Update Posted DateFebruary 23, 2018
Start DateJanuary 01, 2011
Actual Completion DateDecember 01, 2016
Primary Completion DateDecember 01, 2016
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

  • 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.

  • 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.

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleImproving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Official TitleImproving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
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.

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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
24
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Critical Illness
Respiratory Failure
Sleep Deprivation
Sleep Disorders, Circadian Rhythm
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
Behavioral: Usual care

Usual care.

Other Names
Study Groups/Cohorts
Sleep promotion protocol
Behavioral: sleep and circadian rhythm promotion including timed light exposure.

Usual care
Behavioral: usual care.

Study Arms
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.

Arm Intervention/Treatment
Experimental Sleep promotion protocol
Behavioral: sleep and circadian rhythm promotion including timed light exposure.
Behavioral : Sleep and circadian rhythm promotion
Active Comparator Usual care
Behavioral: usual care.
Behavioral : Usual care

Recruitment Information

Recruitment Status:Completed
Enrollment24
Completion DateDecember 01, 2016
Eligibility 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01284140
Other Study ID Numbers
201105754
5K23HL088020
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyBrian Gehlbach, University of Iowa
Study Sponsor
Brian Gehlbach
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator
Brian K Gehlbach, MD
University of Iowa