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Completed

NCT Number: NCT01284140

Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

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.

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Key information

Conditions

Critical Illness Chronobiology Disorders Disease Attributes Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Occupational Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Sleep Deprivation Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep and circadian rhythm promotion

Behavioral

This multifaceted intervention attempts 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. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study.

Usual Care

Behavioral

Usual care.

Primary outcomes

  1. Circadian Timing

    Time frame: Day 1 to 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. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1).

Secondary outcomes

  1. 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.

  2. Circadian Amplitude

    Time frame: Day 3

    The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Brian Gehlbach

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2011
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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