Sleep and Circadian Rhythms in Mechanically Ventilated Patients
This study is currently recruiting participants.
Verified January 2013 by University of Chicago
Sponsor:
University of Chicago
Collaborators:
The Brain Research Foundation
Information provided by (Responsible Party):
Russell Booth Hall, University of Chicago
ClinicalTrials.gov Identifier:
NCT01276652
First received: January 10, 2011
Last updated: January 16, 2013
Last verified: January 2013
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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 enviromental 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 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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: | Russell Booth Hall, Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01276652 History of Changes |
| Other Study ID Numbers: | SleepICU111, 5K23HL088020 |
| Study First Received: | January 10, 2011 |
| Last Updated: | January 16, 2013 |
| 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 May 23, 2013