Bedside Sleep Medicine

August 15, 2013 updated by: Fatima Dumas Cintra, Associação Fundo de Incentivo à Pesquisa

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04128000
        • Recruiting
        • Hospital Sao Paulo - Federal University of Sao Paulo
        • Contact:
        • Principal Investigator:
          • Fatima Cintra, MD, PhD
        • Sub-Investigator:
          • Luciana Storti Mancuso, BSN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
days of admission
Time Frame: 7 days
Days of admission in the cardiology intensive care unit
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Combination of acute myocardial infarction, reinfarction, heart failure and stroke
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Overall mortality
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associação Fundo de Incentivo à Pesquisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bedsidesleep
  • AFIP (Other Grant/Funding Number: AFIP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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