Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

Brian Gehlbach

Status: Completed

Conditions: Respiratory Failure; Critical Illness; Sleep Disorders, Circadian Rhythm; Sleep Deprivation

Treatments: Behavioral: Usual care; Behavioral: Sleep and circadian rhythm promotion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01284140

201105754

5K23HL088020 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sleep promotion protocol

Experimental group

Description:

Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.

Treatment:

Behavioral: Sleep and circadian rhythm promotion

Usual care

Active Comparator group

Description:

Behavioral: 48 hours of usual care.

Treatment:

Behavioral: Usual care