Bedside Sleep Medicine
|ClinicalTrials.gov Identifier: NCT01924507|
Recruitment Status : Unknown
Verified August 2013 by Fatima Dumas Cintra, Associação Fundo de Incentivo à Pesquisa.
Recruitment status was: Recruiting
First Posted : August 16, 2013
Last Update Posted : August 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorders Sleep Apnea Acute Myocardial Infarction Acute Decompensated Heart Failure||Device: CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Cared Bedside Sleep Medicine|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||December 2015|
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.
- days of admission [ Time Frame: 7 days ]Days of admission in the cardiology intensive care unit
- Combination of acute myocardial infarction, reinfarction, heart failure and stroke [ Time Frame: 12 months ]
- Overall mortality [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|