Sleep and Circadian Rhythms in Mechanically Ventilated Patients

NCT01276652 | Completed Results DMC

• 2 other identifiers: SleepICU1115K23HL088020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Critical Illness

Keywords

Polysomnography; Circadian rhythmicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subject Tolerance of the Environmental Modification Protocol

  Average 4 days (patients followed to hospital discharge)

Other Outcomes (2)

• Occurrence of REM Sleep

  Average 4 days (patients followed to hospital discharge)

• Normal Timing of 6-sulfatoxymelatonin Excretion

  Average 4 days (patients followed to hospital discharge)

Study Arms (3)

Environmental modification

ACTIVE COMPARATOR

Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.

Behavioral: Environmental modification

Usual care (randomized)

NO INTERVENTION

Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol.

Usual care (observational)

NO INTERVENTION

Usual care was provided.

Interventions

Environmental modification BEHAVIORAL

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.

Environmental modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Central nervous system disease (stroke, seizure, dementia, etc)
• Metabolic or hypoxic encephalopathy
• Confirmed or suspected drug overdose
• Currently receiving neuromuscular blockers
• Coma

Sponsors & Collaborators

• University of Iowa: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• The Brain Research Foundation: collaborator
• University of Chicago: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Logistical issues related to the performance of continuous bedside polysomnography may vary from institution to institution, thereby limiting the generalizability of our results where the primary outcome measure is concerned.

Results Point of Contact

• Title: Brian Gehlbach, MD
• Organization: University of Iowa

brian-gehlbach@uiowa.edu

319-356-3603

Study Officials

• Brian K Gehlbach, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Jesse Hall, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine

Model Details: Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 13, 2011
• Study Start: November 1, 2001
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 26, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)