Trial Outcomes & Findings for Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients (NCT NCT01284140)
NCT ID: NCT01284140
Last Updated: 2018-05-07
Results Overview
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).
COMPLETED
NA
24 participants
Day 1 to Day 3
2018-05-07
Participant Flow
Subjects were recruited from the medical intensive care units of the University of Chicago and the University of Iowa Hospitals and Clinics.
Two subjects who acutely developed exclusion criteria were withdrawn from the study after enrollment and prior to the performance of any study-related procedures.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.
Participant milestones
| Measure |
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.
|
Usual Care
Behavioral: 48 hours of usual care.
Usual care: Usual care.
|
|---|---|---|
|
Randomization and Intervention
STARTED
|
11
|
11
|
|
Randomization and Intervention
COMPLETED
|
11
|
11
|
|
Randomization and Intervention
NOT COMPLETED
|
0
|
0
|
|
Subjects With Paired 24hr Collections
STARTED
|
11
|
11
|
|
Subjects With Paired 24hr Collections
COMPLETED
|
6
|
5
|
|
Subjects With Paired 24hr Collections
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
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.
|
Usual Care
Behavioral: 48 hours of usual care.
Usual care: Usual care.
|
|---|---|---|
|
Subjects With Paired 24hr Collections
Day 3 urinary profile not available
|
5
|
5
|
|
Subjects With Paired 24hr Collections
Day 1 urinary profile incomplete
|
0
|
1
|
Baseline Characteristics
Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Baseline characteristics by cohort
| Measure |
Sleep Promotion Protocol
n=6 Participants
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.
|
Usual Care
n=5 Participants
Behavioral: usual care.
Usual care: Usual care.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Acute Physiology and Chronic Health Evaluation II score
|
25.5 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
24.4 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
25 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Mechanically ventilated during study period
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Total urinary 6-sulfatoxymelatonin excretion on day 1 (micrograms)
|
14.5 micrograms
STANDARD_DEVIATION 4.7 • n=5 Participants
|
20.4 micrograms
STANDARD_DEVIATION 8.1 • n=7 Participants
|
17.2 micrograms
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Body mass index
|
25.0 kg per meters squared
n=5 Participants
|
27.4 kg per meters squared
n=7 Participants
|
26.4 kg per meters squared
n=5 Participants
|
|
Average peak creatinine during study period
|
2.0 mg per deciliter
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.8 mg per deciliter
STANDARD_DEVIATION 0.5 • n=7 Participants
|
1.9 mg per deciliter
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Propofol during study period
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Opioids during study period
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Benzodiazepines during study period
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Dexmedetomidine during study period
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 3Population: Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.
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).
Outcome measures
| Measure |
Sleep Promotion Protocol
n=6 Participants
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.
|
Usual Care
n=5 Participants
Behavioral: 48 hours of usual care.
Usual care: Usual care.
|
|---|---|---|
|
Circadian Timing
|
3.6 hours
|
-2.4 hours
|
SECONDARY outcome
Timeframe: Day 3Population: Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.
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.
Outcome measures
| Measure |
Sleep Promotion Protocol
n=6 Participants
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.
|
Usual Care
n=5 Participants
Behavioral: 48 hours of usual care.
Usual care: Usual care.
|
|---|---|---|
|
Normal Circadian Timing
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.
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.
Outcome measures
| Measure |
Sleep Promotion Protocol
n=6 Participants
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.
|
Usual Care
n=5 Participants
Behavioral: 48 hours of usual care.
Usual care: Usual care.
|
|---|---|---|
|
Circadian Amplitude
|
36.6 percent of 24-hour mean 6-sulfatoxymelat
Standard Deviation 14.5
|
11.0 percent of 24-hour mean 6-sulfatoxymelat
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Day 2Population: Polysomnography was not conducted on any participants due to logistical constraints.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3Population: Subjects still on study in the ICU on Day 3.
The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups.
Outcome measures
| Measure |
Sleep Promotion Protocol
n=6 Participants
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.
|
Usual Care
n=5 Participants
Behavioral: 48 hours of usual care.
Usual care: Usual care.
|
|---|---|---|
|
Delirium
|
2 Participants
|
2 Participants
|
Adverse Events
Sleep Promotion Protocol
Usual Care
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