Sleep and Circadian Rhythms in Mechanically Ventilated Patients

Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01276652

Enrollment

Registered

2011-01-13

Start date

2001-11-30

Completion date

2008-12-31

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Respiratory Failure

Keywords

Polysomnography, Circadian rhythmicity

Brief summary

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

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.

Interventions

BEHAVIORALEnvironmental 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.	Average 4 days (patients followed to hospital discharge)	This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.

Secondary

Measure	Time frame	Description
Subject Tolerance of the Environmental Modification Protocol	Average 4 days (patients followed to hospital discharge)	This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.

Other

Measure	Time frame	Description
Occurrence of REM Sleep	Average 4 days (patients followed to hospital discharge)	Occurrence of identifiable rapid eye movement (REM) sleep in each subject.
Normal Timing of 6-sulfatoxymelatonin Excretion	Average 4 days (patients followed to hospital discharge)	The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from the medical ICU at the University of Chicago between November 2001 and December 2008. Subjects were randomized to receive the environmental modification or usual care during the first 48 hours beginning the morning after enrollment. Subsequently, we enrolled 5 subjects in an observational arm (usual care).

Pre-assignment details

Two subjects were withdrawn by the PI after consent but prior to randomization, when they acutely developed exclusion criteria. One additional subject was withdrawn by the surrogate decision-maker prior to the initiation of the study. No data were collected on these subjects and they are not included in the results.

Participants by arm

Arm	Count
Environmental Modification Subjects received an environmental modification intervention designed to strengthen day/night routines for the first 48 hours beginning the morning after enrollment. Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.	9
Usual Care (Randomized) Usual Care was provided for the first 48 hours.	8
Usual Care (Observational) Usual care was provided for the first 48 hours.	5
Total	22

Baseline characteristics

Characteristic	Environmental Modification	Usual Care (Randomized)	Usual Care (Observational)	Total
Age, Continuous	62.8 years STANDARD_DEVIATION 22.7	59.4 years STANDARD_DEVIATION 16.8	65.8 years STANDARD_DEVIATION 6	62.2 years STANDARD_DEVIATION 17.4
APACHE II score	22.7 units on a scale STANDARD_DEVIATION 6.6	21.0 units on a scale STANDARD_DEVIATION 8	19.2 units on a scale STANDARD_DEVIATION 6.5	20.9 units on a scale STANDARD_DEVIATION 7.3
Sex: Female, Male Female	5 Participants	5 Participants	3 Participants	13 Participants
Sex: Female, Male Male	4 Participants	3 Participants	2 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	2 / 9	2 / 8	2 / 5
other Total, other adverse events	0 / 9	0 / 8	0 / 5
serious Total, serious adverse events	0 / 9	0 / 8	0 / 5

Outcome results

Primary

Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.

This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.