Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
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|ClinicalTrials.gov Identifier: NCT01284140|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : February 26, 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: sleep and circadian rhythm promotion including timed light exposure.
Behavioral: 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.
Active Comparator: Usual care
Behavioral: usual care.
Behavioral: Usual care
- Circadian timing [ Time Frame: 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.
- 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|