Overview

This trial is active, not recruiting.

Conditions critical illness, sleep deprivation, respiratory failure, sleep disorders, circadian rhythm
Treatments sleep and circadian rhythm promotion, usual care
Phase phase 1
Sponsor University of Iowa
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2011
End date December 2015
Trial size 58 participants
Trial identifier NCT01284140, 11162B, 5K23HL088020

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
Usual care.

Primary Outcomes

Measure
Circadian timing
time frame: Day 3

Secondary Outcomes

Measure
Normal circadian timing
time frame: Day 3
Circadian amplitude
time frame: Day 3
Spectral edge frequency 95%
time frame: Day 2
Delirium
time frame: Day 3

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Principal investigator Brian K Gehlbach, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Iowa.