Bedside Sleep Medicine
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.
Acute Myocardial Infarction
Acute Decompensated Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intensive Cared Bedside Sleep Medicine|
- days of admission [ Time Frame: 7 days ] [ Designated as safety issue: No ]Days of admission in the cardiology intensive care unit
- Combination of acute myocardial infarction, reinfarction, heart failure and stroke [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Overall mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Patients with apnea will be treated with CPAP during the night.
CPAP - continuous positive air pressure in patients with sleep apnea
No Intervention: Control
One arm group will be control and will not receive CPAP treatment during the ICU admission.
At the hospital discharge and after at 1, 3 and 12 months we will evaluate the occurrence of major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01924507
|Contact: Fatima Cintra, MD, PhDfirstname.lastname@example.org|
|Contact: Luciana Storti Mancuso, BSNemail@example.com|
|Hospital Sao Paulo - Federal University of Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 04128000|
|Contact: Fatima Cintra, MD, PhD 55-11-55764618 firstname.lastname@example.org|
|Principal Investigator: Fatima Cintra, MD, PhD|
|Sub-Investigator: Luciana Storti Mancuso, BSN|