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
Sponsor Brian Gehlbach
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2011
End date December 2016
Trial size 24 participants
Trial identifier NCT01284140, 201105754, 5K23HL088020


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
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Behavioral: sleep and circadian rhythm promotion including timed light exposure.
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)
Behavioral: usual care.
usual care
Usual care.

Primary Outcomes

Circadian timing
time frame: Day 3

Secondary Outcomes

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

Eligibility Criteria

All 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 February 2017.
Information provided to ClinicalTrials.gov by University of Iowa.