Sleep and Circadian Rhythms in Mechanically Ventilated Patients

Critical Illness Clinical Trial

Official title:

Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276652
• Other study ID #: SleepICU111
• Secondary ID: 5K23HL088020
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: July 25, 2017
• Start date: November 2001
• Est. completion date: December 2008

Study information

• Verified date: July 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.

Description:

Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults undergoing mechanical ventilation in the medical intensive care unit.

Exclusion Criteria:

• Central nervous system disease (stroke, seizure, dementia, etc)

• Metabolic or hypoxic encephalopathy

• Confirmed or suspected drug overdose

• Currently receiving neuromuscular blockers

• Coma

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Behavioral:
• Environmental modification
Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Iowa	National Heart, Lung, and Blood Institute (NHLBI), The Brain Research Foundation, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of REM Sleep	Occurrence of identifiable rapid eye movement (REM) sleep in each subject.	Average 4 days (patients followed to hospital discharge)
Other	Normal Timing of 6-sulfatoxymelatonin Excretion	The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.	Average 4 days (patients followed to hospital discharge)
Primary	Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.	This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.	Average 4 days (patients followed to hospital discharge)
Secondary	Subject Tolerance of the Environmental Modification Protocol	This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.	Average 4 days (patients followed to hospital discharge)