Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
|ClinicalTrials.gov Identifier: NCT01284140|
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Sleep Deprivation Respiratory Failure Sleep Disorders, Circadian Rhythm||Behavioral: Sleep and circadian rhythm promotion Behavioral: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Sleep promotion protocol
Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.
Behavioral: 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.
Active Comparator: Usual care
Behavioral: 48 hours of usual care.
Behavioral: Usual care
- Circadian Timing [ Time Frame: Day 1 to 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).
- Normal Circadian Timing [ Time Frame: 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.
- Circadian Amplitude [ Time Frame: 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.
- Spectral Edge Frequency 95% [ Time Frame: Day 2 ]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.
- Delirium [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284140
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Brian K Gehlbach, MD||University of Iowa|