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Bedside Sleep Medicine

Primary Purpose

Sleep Disorders, Sleep Apnea, Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
Associação Fundo de Incentivo à Pesquisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring Sleep medicine, Sleep apnea, Acute myocardial infarction, Heart failure, CPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sao Paulo - Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP

Control

Arm Description

Patients with apnea will be treated with CPAP during the night.

One arm group will be control and will not receive CPAP treatment during the ICU admission.

Outcomes

Primary Outcome Measures

days of admission
Days of admission in the cardiology intensive care unit

Secondary Outcome Measures

Combination of acute myocardial infarction, reinfarction, heart failure and stroke

Full Information

First Posted
August 14, 2013
Last Updated
August 15, 2013
Sponsor
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01924507
Brief Title
Bedside Sleep Medicine
Official Title
Intensive Cared Bedside Sleep Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Sleep Apnea, Acute Myocardial Infarction, Acute Decompensated Heart Failure
Keywords
Sleep medicine, Sleep apnea, Acute myocardial infarction, Heart failure, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
Patients with apnea will be treated with CPAP during the night.
Arm Title
Control
Arm Type
No Intervention
Arm Description
One arm group will be control and will not receive CPAP treatment during the ICU admission.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP - continuous positive air pressure in patients with sleep apnea
Primary Outcome Measure Information:
Title
days of admission
Description
Days of admission in the cardiology intensive care unit
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Combination of acute myocardial infarction, reinfarction, heart failure and stroke
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Overall mortality
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Cintra, MD, PhD
Phone
55-11-55764618
Email
fatimacintra@interair.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Storti Mancuso, BSN
Phone
55-11-55764230
Email
ljstorti@hotmail.com
Facility Information:
Facility Name
Hospital Sao Paulo - Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04128000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima Cintra, MD, PhD
Phone
55-11-55764618
Email
fatimacintra@interair.com.br
First Name & Middle Initial & Last Name & Degree
Fatima Cintra, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luciana Storti Mancuso, BSN

12. IPD Sharing Statement

Citations:
PubMed Identifier
10194160
Citation
Freedman NS, Kotzer N, Schwab RJ. Patient perception of sleep quality and etiology of sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1155-62. doi: 10.1164/ajrccm.159.4.9806141.
Results Reference
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PubMed Identifier
11227580
Citation
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
Results Reference
background
PubMed Identifier
9122557
Citation
Aaron JN, Carlisle CC, Carskadon MA, Meyer TJ, Hill NS, Millman RP. Environmental noise as a cause of sleep disruption in an intermediate respiratory care unit. Sleep. 1996 Nov;19(9):707-10. doi: 10.1093/sleep/19.9.707.
Results Reference
background
PubMed Identifier
23770166
Citation
Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.
Results Reference
background
PubMed Identifier
22983957
Citation
Martinez-Garcia MA, Campos-Rodriguez F, Catalan-Serra P, Soler-Cataluna JJ, Almeida-Gonzalez C, De la Cruz Moron I, Duran-Cantolla J, Montserrat JM. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):909-16. doi: 10.1164/rccm.201203-0448OC. Epub 2012 Sep 13.
Results Reference
background
PubMed Identifier
21185560
Citation
Elliott R, McKinley S, Cistulli P. The quality and duration of sleep in the intensive care setting: an integrative review. Int J Nurs Stud. 2011 Mar;48(3):384-400. doi: 10.1016/j.ijnurstu.2010.11.006. Epub 2010 Dec 24.
Results Reference
background
PubMed Identifier
15781100
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.
Results Reference
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Bedside Sleep Medicine

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