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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 |
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The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.
Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep promotion protocol | Experimental | Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure. |
|
| Usual care | Active Comparator | Behavioral: 48 hours of usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep and circadian rhythm promotion | Behavioral | This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Timing | The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1). | Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Normal Circadian Timing | The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups. | Day 3 |
| Circadian Amplitude |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian K Gehlbach, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| University of Iowa Hospitals and Clinics |
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Two subjects who acutely developed exclusion criteria were withdrawn from the study after enrollment and prior to the performance of any study-related procedures. These subjects were not analyzed.
Subjects were recruited from the medical intensive care units of the University of Chicago and the University of Iowa Hospitals and Clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Promotion Protocol | Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure. Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study. |
| FG001 | Usual Care | Behavioral: 48 hours of usual care. Usual care: Usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization and Intervention |
| |||||||||||||
| Subjects With Paired 24hr Collections |
|
Subjects with 24-hour urinary 6-sulfatoxymelatonin profiles from both Day 1 and Day 3 were analyzed (11 subjects out of a total of 22). One of the remaining subjects had an unevaluable profile from Day 1. The remaining subjects died or had their urinary catheter removed prior to Day 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Promotion Protocol | Behavioral: sleep and circadian rhythm promotion including timed light exposure. Sleep and circadian rhythm promotion: This multifaceted intervention will attempt to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. Supplemental bright lights and eyeshades and noise cancelling headphones may also be employed. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Circadian Timing | The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1). | Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3. | Posted | Number | hours | Day 1 to Day 3 |
|
From the day of enrollment until the completion of all bedside assessments 3 days later.
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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 | Sleep Promotion Protocol | Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure. Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study. |
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Lower dose light intervention received by one subject; the study design resulted in significant attrition, limiting the number of evaluable patients; baseline differences in the timing of maximal melatonin excretion may have influenced the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian K. Gehlbach, MD | University of Iowa | 319-356-3603 | brian-gehlbach@uiowa.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012892 | Sleep Deprivation |
| D012131 | Respiratory Insufficiency |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Usual care | Behavioral | Usual care. |
|
The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.
| Day 3 |
| Spectral Edge Frequency 95% | The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups. | Day 2 |
| Delirium | The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups. | Day 3 |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| NOT COMPLETED |
|
|
| BG001 | Usual Care | Behavioral: usual care. Usual care: Usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Acute Physiology and Chronic Health Evaluation II score | The Acute Physiology and Chronic Health Evaluation (APACHE) II score is a severity of illness score that estimates ICU mortality. An integer score from 0 to 71 is computed based on several measurements, with higher scores corresponding to higher predicted mortality. | Mean | Standard Deviation | units on a scale |
|
| Mechanically ventilated during study period | Count of Participants | Participants |
|
| Total urinary 6-sulfatoxymelatonin excretion on day 1 (micrograms) | Mean | Standard Deviation | micrograms |
|
| Body mass index | Median | Inter-Quartile Range | kg per meters squared |
|
| Average peak creatinine during study period | Mean | Standard Deviation | mg per deciliter |
|
| Propofol during study period | Count of Participants | Participants |
|
| Opioids during study period | Count of Participants | Participants |
|
| Benzodiazepines during study period | Count of Participants | Participants |
|
| Dexmedetomidine during study period | Count of Participants | Participants |
|
| OG001 | Usual Care | Behavioral: 48 hours of usual care. Usual care: Usual care. |
|
|
|
| Secondary | Normal Circadian Timing | The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups. | Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3. | Posted | Count of Participants | Participants | Day 3 |
|
|
|
|
| Secondary | Circadian Amplitude | The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups. | Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3. | Posted | Mean | Standard Deviation | percent of 24-hour mean 6-sulfatoxymelat | Day 3 |
|
|
|
|
| Secondary | Spectral Edge Frequency 95% | The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups. | Polysomnography was not conducted on any participants due to logistical constraints. | Posted | Day 2 |
|
|
| Secondary | Delirium | The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups. | Subjects still on study in the ICU on Day 3. | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| 4 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Usual Care | Behavioral: 48 hours of usual care. Usual care: Usual care. | 2 | 11 | 0 | 11 | 0 | 11 |
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| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D021081 | Chronobiology Disorders |
| D009784 | Occupational Diseases |