Trial record 19 of 244 for:    sleep studies OR polysomnogram OR multiple sleep latency test OR maintenance of wakefulness test | Open Studies | NIH, U.S. Fed

Sleep and Circadian Rhythms in Mechanically Ventilated Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Collaborators:
The Brain Research Foundation
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01276652
First received: January 10, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Respiratory Failure
Critical Illness
Behavioral: Environmental modification
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Feasibility of studying sleep and circadian rhythms in acutely ill, mechanically ventilated patients. [ Time Frame: Average 2 weeks (patients followed to hospital discharge) ] [ Designated as safety issue: No ]
    This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients utilizing continuous bedside polysomnography and the collection of urinary samples for 6-sulfatoxymelatonin analysis.


Secondary Outcome Measures:
  • Feasibility of strengthening the day/night routine of acutely ill, mechanically ventilated patients. [ Time Frame: Average 2 weeks (patients followed to hospital discharge) ] [ Designated as safety issue: No ]
    A subset of subjects will be randomly assigned to receive routine care according to a classical day/night routine (rather than a 24-hour care cycle) at various points in time. The feasibility of employing additional measures to limit environmental disruption, such as the use of eyeshades and noise reduction strategies, will also be explored.


Estimated Enrollment: 25
Study Start Date: November 2001
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Environmental modification Behavioral: Environmental modification
For a subset of patients, the feasibility of delivering routine care according to classic day/night routines and of reducing exposure to environmental light and sound will be assessed.
No Intervention: Usual care

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276652

Contacts
Contact: Anne S Pohlman, RN, MSN 773-702-3804 apohlman@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Anne S Pohlman, RN, MSN    773-702-3804    apohlman@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
The Brain Research Foundation
Investigators
Principal Investigator: Brian K Gehlbach, MD University of Chicago
Principal Investigator: Jesse Hall, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01276652     History of Changes
Other Study ID Numbers: SleepICU111, 5K23HL088020
Study First Received: January 10, 2011
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Polysomnography
Circadian rhythmicity

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014