Sleep and Circadian Rhythms in Mechanically Ventilated Patients

University of Iowa

Status: Completed

Conditions: Respiratory Failure; Critical Illness

Treatments: Behavioral: Environmental modification

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01276652

SleepICU111

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

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Environmental modification

Active Comparator group

Description:

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

Treatment:

Behavioral: Environmental modification

Usual care (randomized)

No Intervention group

Description:

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.

Usual care (observational)

No Intervention group

Description:

Usual care was provided.