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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL088020 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| The Brain Research Foundation | OTHER |
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Environmental modification | Active Comparator | Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment. |
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| Usual care (randomized) | No Intervention | 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 | Usual care was provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Environmental modification | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Average 4 days (patients followed to hospital discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Tolerance of the Environmental Modification Protocol | 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. | Average 4 days (patients followed to hospital discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of REM Sleep | Occurrence of identifiable rapid eye movement (REM) sleep in each subject. | Average 4 days (patients followed to hospital discharge) |
| Normal Timing of 6-sulfatoxymelatonin Excretion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian K Gehlbach, MD | University of Chicago | Principal Investigator |
| Jesse Hall, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
As this is a pilot study, there are no plans to share IPD.
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomization: Environmental Modification Group | Subjects randomized to this group underwent the environmental modification intervention designed to promote strong day/night routines for 48 hours. |
| FG001 | 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. |
| FG002 | Usual Care (Observational) | Subjects received usual care for 48 hours beginning the morning after enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Randomization |
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| Period 2: Observational |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Average 4 days (patients followed to hospital discharge) |
|
Until ICU discharge, an average of 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Environmental Modification | Environmental modification is provided for the initial 48 hours and consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night. |
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Logistical issues related to the performance of continuous bedside polysomnography may vary from institution to institution, thereby limiting the generalizability of our results where the primary outcome measure is concerned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Gehlbach, MD | University of Iowa | 319-356-3603 | brian-gehlbach@uiowa.edu |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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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.
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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.
| Average 4 days (patients followed to hospital discharge) |
| NOT COMPLETED |
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| BG001 | Usual Care (Randomized) | Usual Care was provided for the first 48 hours. |
| BG002 | Usual Care (Observational) | Usual care was provided for the first 48 hours. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| APACHE II score | The Acute Physiology and Chronic Health Evaluation II score is designed to measure the severity of illness of patients admitted to intensive care units, with higher scores indicating patients who are more likely to die during the admission. The score is an integer score that ranges from 0 to 71 and is calculated within 24 hours of admission from the patient's age, routinely collected physiologic data, and information regarding the patient's chronic health status. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care (Randomized) | Usual Care was provided during the first 48 hours. |
| OG002 | Usual Care (Observational) | Usual care was provided for 48 hours. |
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| Secondary | Subject Tolerance of the Environmental Modification Protocol | 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. | Only subjects who received the intervention were assessed. | Posted | Number | Subjects who tolerated the protocol | Average 4 days (patients followed to hospital discharge) |
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| Other Pre-specified | Occurrence of REM Sleep | Occurrence of identifiable rapid eye movement (REM) sleep in each subject. | In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed. | Posted | Count of Participants | Participants | Average 4 days (patients followed to hospital discharge) |
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| Other Pre-specified | Normal Timing of 6-sulfatoxymelatonin Excretion | 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. | 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. | Posted | Count of Participants | Participants | Average 4 days (patients followed to hospital discharge) |
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| Post-Hoc | Presence of Normal Slow Wave Activity | 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. | In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed. | Posted | Count of Participants | Participants | Average 4 days (patients followed to hospital discharge) |
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| Post-Hoc | Presence of Normal Spectral Edge Frequency 95% (SEF95) Activity | 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. | In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed. | Posted | Count of Participants | Participants | Average 4 days (patients followed to hospital discharge) |
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| 2 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Usual Care (Randomized) | Usual care is provided to the subjects. | 2 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Usual Care (Observational) | Usual care is provided to the subjects. | 2 | 5 | 0 | 5 | 0 | 5 |
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| D013568 | Pathological Conditions, Signs and Symptoms |