Trial Outcomes & Findings for Sleep and Circadian Rhythms in Mechanically Ventilated Patients (NCT NCT01276652)
NCT ID: NCT01276652
Last Updated: 2017-09-26
Results Overview
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.
COMPLETED
NA
25 participants
Average 4 days (patients followed to hospital discharge)
2017-09-26
Participant Flow
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).
Two subjects were withdrawn by the PI after consent but prior to randomization, when they acutely developed exclusion criteria. One additional subject was withdrawn by the surrogate decision-maker prior to the initiation of the study.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.
Participant milestones
| Measure |
Randomization: Environmental Modification Group
Subjects randomized to this group underwent the environmental modification intervention designed to promote strong day/night routines for 48 hours.
|
Randomization: Usual Care
Subjects received usual care for 48 hours beginning the morning after enrollment. A subset of this group received the intervention on a pilot basis after this time period had elapsed.
|
Usual Care (Observational)
Subjects received usual care for 48 hours beginning the morning after enrollment.
|
|---|---|---|---|
|
Period 1: Randomization
STARTED
|
9
|
8
|
0
|
|
Period 1: Randomization
COMPLETED
|
9
|
8
|
0
|
|
Period 1: Randomization
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2: Observational
STARTED
|
9
|
8
|
5
|
|
Period 2: Observational
COMPLETED
|
9
|
8
|
5
|
|
Period 2: Observational
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep and Circadian Rhythms in Mechanically Ventilated Patients
Baseline characteristics by cohort
| Measure |
Environmental Modification
n=9 Participants
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.
|
Usual Care (Randomized)
n=8 Participants
Usual Care was provided for the first 48 hours.
|
Usual Care (Observational)
n=5 Participants
Usual care was provided for the first 48 hours.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 22.7 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 17.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
APACHE II score
|
22.7 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
21.0 units on a scale
STANDARD_DEVIATION 8.0 • n=7 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
20.9 units on a scale
STANDARD_DEVIATION 7.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Environmental Modification
n=9 Participants
A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). 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.
|
Usual Care (Randomized)
n=8 Participants
Usual Care was provided during the first 48 hours.
|
Usual Care (Observational)
n=5 Participants
Usual care was provided for 48 hours.
|
|---|---|---|---|
|
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.
|
9 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Average 4 days (patients followed to hospital discharge)Population: Only subjects who received the intervention were assessed.
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.
Outcome measures
| Measure |
Environmental Modification
n=9 Participants
A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). 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.
|
Usual Care (Randomized)
Usual Care was provided during the first 48 hours.
|
Usual Care (Observational)
Usual care was provided for 48 hours.
|
|---|---|---|---|
|
Subject Tolerance of the Environmental Modification Protocol
|
9 Subjects who tolerated the protocol
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Average 4 days (patients followed to hospital discharge)Population: In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.
Occurrence of identifiable rapid eye movement (REM) sleep in each subject.
Outcome measures
| Measure |
Environmental Modification
n=8 Participants
A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). 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.
|
Usual Care (Randomized)
n=8 Participants
Usual Care was provided during the first 48 hours.
|
Usual Care (Observational)
n=5 Participants
Usual care was provided for 48 hours.
|
|---|---|---|---|
|
Occurrence of REM Sleep
|
2 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Average 4 days (patients followed to hospital discharge)Population: 24-hour 6-sulfatoxymelatonin profiles were successfully collected in 16 subjects total. In one subject in the usual care (observational) group, there were insufficient data to determine melatonin timing.
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.
Outcome measures
| Measure |
Environmental Modification
n=5 Participants
A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). 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.
|
Usual Care (Randomized)
n=6 Participants
Usual Care was provided during the first 48 hours.
|
Usual Care (Observational)
n=4 Participants
Usual care was provided for 48 hours.
|
|---|---|---|---|
|
Normal Timing of 6-sulfatoxymelatonin Excretion
|
1 Participants
|
2 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: Average 4 days (patients followed to hospital discharge)Population: In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.
Slow wave activity in health exhibits diurnal and ultradian periodicity and a homeostatic decline at night. The number of subjects exhibiting these characteristics was calculated for each group.
Outcome measures
| Measure |
Environmental Modification
n=8 Participants
A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). 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.
|
Usual Care (Randomized)
n=8 Participants
Usual Care was provided during the first 48 hours.
|
Usual Care (Observational)
n=5 Participants
Usual care was provided for 48 hours.
|
|---|---|---|---|
|
Presence of Normal Slow Wave Activity
|
0 Participants
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Average 4 days (patients followed to hospital discharge)Population: In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.
SEF95 is normally higher during wakefulness during sleep. The normal sleep SEF95 profile is rhythmic with an approximately 90 minute periodicity. We analyzed the number of subjects who exhibited this normal profile.
Outcome measures
| Measure |
Environmental Modification
n=8 Participants
A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). 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.
|
Usual Care (Randomized)
n=8 Participants
Usual Care was provided during the first 48 hours.
|
Usual Care (Observational)
n=5 Participants
Usual care was provided for 48 hours.
|
|---|---|---|---|
|
Presence of Normal Spectral Edge Frequency 95% (SEF95) Activity
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Environmental Modification
Usual Care (Randomized)
Usual Care (Observational)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place