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Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Brian Gehlbach
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: February 16, 2017
Last verified: February 2017
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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 |
|---|---|
| Critical Illness Sleep Deprivation Respiratory Failure Sleep Disorders, Circadian Rhythm | Behavioral: Sleep and circadian rhythm promotion Behavioral: Usual care |
| Study Type: | Interventional |
| Study Design: | 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 |
Further study details as provided by Brian Gehlbach, University of Iowa:
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.
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.
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | August 2017 |
| 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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01284140
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
Brian Gehlbach
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: |
201105754 5K23HL088020 ( U.S. NIH Grant/Contract ) |
| Study First Received: | January 19, 2011 |
| Last Updated: | February 16, 2017 |
| 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 |
ClinicalTrials.gov processed this record on August 23, 2017