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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
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Brian Gehlbach, University of Iowa

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Critical Illness
Sleep Deprivation
Respiratory Failure
Sleep Disorders, Circadian Rhythm
Interventions: Behavioral: Sleep and circadian rhythm promotion
Behavioral: Usual care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the medical intensive care units of the University of Chicago and the University of Iowa Hospitals and Clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two subjects who acutely developed exclusion criteria were withdrawn from the study after enrollment and prior to the performance of any study-related procedures.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.

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   Randomization and Intervention
    Sleep Promotion Protocol   Usual Care
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 

Period 2:   Subjects With Paired 24hr Collections
    Sleep Promotion Protocol   Usual Care
STARTED   11   11 
COMPLETED   6   5 
NOT COMPLETED   5   6 
Day 3 urinary profile not available                5                5 
Day 1 urinary profile incomplete                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.

Usual Care

Behavioral: usual care.

Usual care: Usual care.

Total Total of all reporting groups

Baseline Measures
   Sleep Promotion Protocol   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   5   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.2  (10.4)   59.6  (7.7)   63.7  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  50.0%      2  40.0%      5  45.5% 
Male      3  50.0%      3  60.0%      6  54.5% 
Region of Enrollment 
[Units: Participants]
     
United States   6   5   11 
Acute Physiology and Chronic Health Evaluation II score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 25.5  (2.5)   24.4  (2.0)   25  (5.3) 
[1] 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.
Mechanically ventilated during study period 
[Units: Participants]
Count of Participants
 6   5   11 
Total urinary 6-sulfatoxymelatonin excretion on day 1 (micrograms) 
[Units: Micrograms]
Mean (Standard Deviation)
 14.5  (4.7)   20.4  (8.1)   17.2  (14.5) 
Body mass index 
[Units: Kg per meters squared]
Median (Inter-Quartile Range)
 25.0 
 (21.8 to 33.2) 
 27.4 
 (26.0 to 37.9) 
 26.4 
 (24 to 35.5) 
Average peak creatinine during study period 
[Units: Mg per deciliter]
Mean (Standard Deviation)
 2.0  (0.6)   1.8  (0.5)   1.9  (1.3) 
Propofol during study period 
[Units: Participants]
Count of Participants
 6   5   11 
Opioids during study period 
[Units: Participants]
Count of Participants
 6   5   11 
Benzodiazepines during study period 
[Units: Participants]
Count of Participants
 0   3   3 
Dexmedetomidine during study period 
[Units: Participants]
Count of Participants
 0   1   1 


  Outcome Measures

1.  Primary:   Circadian Timing   [ Time Frame: Day 1 to Day 3 ]

2.  Secondary:   Normal Circadian Timing   [ Time Frame: Day 3 ]

3.  Secondary:   Circadian Amplitude   [ Time Frame: Day 3 ]

4.  Secondary:   Spectral Edge Frequency 95%   [ Time Frame: Day 2 ]

5.  Secondary:   Delirium   [ Time Frame: Day 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brian K. Gehlbach, MD
Organization: University of Iowa
phone: 319-356-3603
e-mail: brian-gehlbach@uiowa.edu



Responsible Party: Brian Gehlbach, University of Iowa
ClinicalTrials.gov Identifier: NCT01284140     History of Changes
Other Study ID Numbers: 201105754
5K23HL088020 ( U.S. NIH Grant/Contract )
First Submitted: January 19, 2011
First Posted: January 26, 2011
Results First Submitted: March 23, 2018
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018