Bedside Sleep Medicine

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Associação Fundo de Incentivo à Pesquisa
Sponsor:
Information provided by (Responsible Party):
Fatima Dumas Cintra, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01924507
First received: August 14, 2013
Last updated: August 15, 2013
Last verified: August 2013

August 14, 2013
August 15, 2013
August 2013
August 2013   (final data collection date for primary outcome measure)
days of admission [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Days of admission in the cardiology intensive care unit
Same as current
Complete list of historical versions of study NCT01924507 on ClinicalTrials.gov Archive Site
Combination of acute myocardial infarction, reinfarction, heart failure and stroke [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Overall mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
 
Bedside Sleep Medicine
Intensive Cared 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Disorders
  • Sleep Apnea
  • Acute Myocardial Infarction
  • Acute Decompensated Heart Failure
Device: CPAP
CPAP - continuous positive air pressure in patients with sleep apnea
  • Experimental: CPAP
    Patients with apnea will be treated with CPAP during the night.
    Intervention: Device: CPAP
  • No Intervention: Control
    One arm group will be control and will not receive CPAP treatment during the ICU admission.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2015
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Fatima Cintra, MD, PhD 55-11-55764618 fatimacintra@interair.com.br
Contact: Luciana Storti Mancuso, BSN 55-11-55764230 ljstorti@hotmail.com
Brazil
 
NCT01924507
bedsidesleep, AFIP
No
Fatima Dumas Cintra, Associação Fundo de Incentivo à Pesquisa
Associação Fundo de Incentivo à Pesquisa
Not Provided
Not Provided
Associação Fundo de Incentivo à Pesquisa
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP