Bedside Sleep Medicine

Acute Myocardial Infarction Clinical Trial

Official title:

Intensive Cared Bedside Sleep Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01924507
• Other study ID #: bedsidesleep
• Secondary ID: AFIP
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2013
• Last updated: August 15, 2013
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2013
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: Fatima Cintra, MD, PhD
• Phone: 55-11-55764618
• Email: fatimacintra[@]interair.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction
• Parasomnias
• Sleep Apnea
• Sleep Disorders

Intervention

Device:
• CPAP
CPAP - continuous positive air pressure in patients with sleep apnea

Locations

Country	Name	City	State
Brazil	Hospital Sao Paulo - Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Martínez-García MA, Campos-Rodríguez F, Catalán-Serra P, Soler-Cataluña JJ, Almeida-Gonzalez C, De la Cruz Morón I, Durán-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall mortality		12 months	No
Primary	days of admission	Days of admission in the cardiology intensive care unit	7 days	No
Secondary	Combination of acute myocardial infarction, reinfarction, heart failure and stroke		12 months	No