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Bedside Sleep Medicine

A

Associação Fundo de Incentivo à Pesquisa

Status

Unknown

Conditions

Sleep Disorders
Acute Decompensated Heart Failure
Sleep Apnea
Acute Myocardial Infarction

Treatments

Device: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT01924507
AFIP (Other Grant/Funding Number)
bedsidesleep

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

CPAP
Experimental group
Description:
Patients with apnea will be treated with CPAP during the night.
Treatment:
Device: CPAP
Control
No Intervention group
Description:
One arm group will be control and will not receive CPAP treatment during the ICU admission.

Trial contacts and locations

1

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Central trial contact

Luciana Storti Mancuso, BSN; Fatima Cintra, MD, PhD

Data sourced from clinicaltrials.gov

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