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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Cared Bedside Sleep Medicine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • days of admission [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Overall mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924507

Contacts
Contact: Fatima Cintra, MD, PhD 55-11-55764618 fatimacintra@interair.com.br
Contact: Luciana Storti Mancuso, BSN 55-11-55764230 ljstorti@hotmail.com

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

Publications:

Responsible Party: Fatima Dumas Cintra, MD, PhD, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01924507     History of Changes
Other Study ID Numbers: bedsidesleep, AFIP
Study First Received: August 14, 2013
Last Updated: August 15, 2013
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Apnea
Heart Failure
Infarction
Myocardial Infarction
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014