Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
This study is ongoing, but not recruiting participants.
Sponsor:
University of Iowa
Collaborator:
Information provided by (Responsible Party):
Brian Gehlbach, University of Iowa
ClinicalTrials.gov Identifier:
NCT01284140
First received: January 19, 2011
Last updated: December 9, 2014
Last verified: December 2014
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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 | 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: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (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
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
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 9, 2014 |
| 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:
|
Critical Illness Respiratory Insufficiency Sleep Deprivation Sleep Disorders, Circadian Rhythm Chronobiology Disorders Disease Attributes Dyssomnias Mental Disorders |
Nervous System Diseases Neurologic Manifestations Occupational Diseases Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Disorders |
ClinicalTrials.gov processed this record on March 03, 2015