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Sleep and Circadian Rhythms in Mechanically Ventilated Patients

NCT ID: NCT01276652

Last Updated: 2017-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2008-12-31

Brief Summary

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This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.

Detailed Description

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Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.

Conditions

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Respiratory Failure Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Environmental modification

Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.

Group Type ACTIVE_COMPARATOR

Environmental modification

Intervention Type BEHAVIORAL

Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.

Usual care (randomized)

Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Usual care (observational)

Usual care was provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Environmental modification

Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults undergoing mechanical ventilation in the medical intensive care unit.

Exclusion Criteria

* Central nervous system disease (stroke, seizure, dementia, etc)
* Metabolic or hypoxic encephalopathy
* Confirmed or suspected drug overdose
* Currently receiving neuromuscular blockers
* Coma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

The Brain Research Foundation

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Brian Gehlbach

Clinical Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian K Gehlbach, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Jesse Hall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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5K23HL088020

Identifier Type: NIH

Identifier Source: secondary_id

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SleepICU111

Identifier Type: -

Identifier Source: org_study_id