Bedside Sleep Medicine
Intensive Cared Bedside Sleep Medicine
2 other identifiers
interventional
400
1 country
1
Brief Summary
The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology intensive care unit. The patients will be submitted to a overnight polysomnography. Those individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the investigators will identify the factors that compromise the sleep and will act to minimize them to improve the sleep quality. After the interventions, the investigators will evaluate if there are reduced days of hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 16, 2013
August 1, 2013
Same day
August 14, 2013
August 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
days of admission
Days of admission in the cardiology intensive care unit
7 days
Secondary Outcomes (1)
Combination of acute myocardial infarction, reinfarction, heart failure and stroke
12 months
Other Outcomes (1)
Overall mortality
12 months
Study Arms (2)
CPAP
EXPERIMENTALPatients with apnea will be treated with CPAP during the night.
Control
NO INTERVENTIONOne arm group will be control and will not receive CPAP treatment during the ICU admission.
Interventions
Eligibility Criteria
You may qualify if:
- Acute myocardial infarction
- Acute decompensated heart failure
- Age \> 18 years-old
- Cardiology intensive care unit admission
You may not qualify if:
- Intravenous sedation
- Invasive mechanical ventilation
- hemodynamic instability
- use of intravenous vasoactive drugs
- acute respiratory failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Sao Paulo - Federal University of Sao Paulo
São Paulo, São Paulo, 04128000, Brazil
Related Publications (7)
Freedman NS, Kotzer N, Schwab RJ. Patient perception of sleep quality and etiology of sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1155-62. doi: 10.1164/ajrccm.159.4.9806141.
PMID: 10194160BACKGROUNDRichards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PMID: 11227580BACKGROUNDAaron JN, Carlisle CC, Carskadon MA, Meyer TJ, Hill NS, Millman RP. Environmental noise as a cause of sleep disruption in an intermediate respiratory care unit. Sleep. 1996 Nov;19(9):707-10. doi: 10.1093/sleep/19.9.707.
PMID: 9122557BACKGROUNDGami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.
PMID: 23770166BACKGROUNDMartinez-Garcia MA, Campos-Rodriguez F, Catalan-Serra P, Soler-Cataluna JJ, Almeida-Gonzalez C, De la Cruz Moron I, Duran-Cantolla J, Montserrat JM. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):909-16. doi: 10.1164/rccm.201203-0448OC. Epub 2012 Sep 13.
PMID: 22983957BACKGROUNDElliott R, McKinley S, Cistulli P. The quality and duration of sleep in the intensive care setting: an integrative review. Int J Nurs Stud. 2011 Mar;48(3):384-400. doi: 10.1016/j.ijnurstu.2010.11.006. Epub 2010 Dec 24.
PMID: 21185560BACKGROUNDMarin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
PMID: 15781100BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 16, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2013
Study Completion
December 1, 2015
Last Updated
August 16, 2013
Record last verified: 2013-08