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Bedside Sleep Medicine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Associação Fundo de Incentivo à Pesquisa.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Fatima Dumas Cintra, Associação Fundo de Incentivo à Pesquisa Identifier:
First received: August 14, 2013
Last updated: August 15, 2013
Last verified: August 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 Intervention
Sleep Disorders
Sleep Apnea
Acute Myocardial Infarction
Acute Decompensated Heart Failure
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Cared Bedside Sleep Medicine

Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • days of admission [ Time Frame: 7 days ]
    Days of admission in the cardiology intensive care unit

Secondary Outcome Measures:
  • Combination of acute myocardial infarction, reinfarction, heart failure and stroke [ Time Frame: 12 months ]

Other Outcome Measures:
  • Overall mortality [ Time Frame: 12 months ]

Estimated Enrollment: 400
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)
Arms Assigned Interventions
Experimental: CPAP
Patients with apnea will be treated with CPAP during the night.
Device: CPAP
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01924507

Contact: Fatima Cintra, MD, PhD 55-11-55764618
Contact: Luciana Storti Mancuso, BSN 55-11-55764230

Hospital Sao Paulo - Federal University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04128000
Contact: Fatima Cintra, MD, PhD    55-11-55764618   
Principal Investigator: Fatima Cintra, MD, PhD         
Sub-Investigator: Luciana Storti Mancuso, BSN         
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
  More Information


Responsible Party: Fatima Dumas Cintra, MD, PhD, Associação Fundo de Incentivo à Pesquisa Identifier: NCT01924507     History of Changes
Other Study ID Numbers: bedsidesleep
AFIP ( Other Grant/Funding Number: AFIP )
Study First Received: August 14, 2013
Last Updated: August 15, 2013

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
Sleep medicine
Sleep apnea
Acute myocardial infarction
Heart failure

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Sleep Apnea Syndromes
Sleep Wake Disorders
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders processed this record on May 22, 2017