Clinical trial NCT01924507: Bedside Sleep Medicine
Official title: Intensive Cared Bedside Sleep Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorders
Sleep Apnea
Acute Myocardial Infarction
Acute Decompensated Heart Failure
Keywords: Sleep medicine
Sleep apnea
Acute myocardial infarction
Heart failure
CPAP
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction
* Acute decompensated heart failure
* Age \> 18 years-old
* Cardiology intensive care unit admission

Exclusion Criteria:

* Intravenous sedation
* Invasive mechanical ventilation
* hemodynamic instability
* use of intravenous vasoactive drugs
* acute respiratory failure

Primary outcomes:
measure: days of admission
timeFrame: 7 days
Secondary outcomes:
measure: Combination of acute myocardial infarction, reinfarction, heart failure and stroke
timeFrame: 12 months
Other outcomes:
measure: Overall mortality
timeFrame: 12 months
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo - Federal University of Sao Paulo
state: SP
Study officials:
References:
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citation: Marin 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.