Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness

This study has been completed.

First Received on August 4, 2005. Last Updated on April 2, 2007 History of Changes

Sponsor:	Sociedad Española de Neumología y Cirugía Torácica
Information provided by:	Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:	NCT00127348

Purpose

The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.

The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications.

The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events.

All patients, after randomization, will be followed for three years.

Condition	Intervention	Phase
Sleep Apnea Hypertension Cardiovascular Diseases	Device: CPAP (Continuous Positive Airway Pressure)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Sleep Apnea

U.S. FDA Resources

Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:

Incidence of hypertension
Incidence of cardiovascular events

Secondary Outcome Measures:

Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
Relationship between cardiovascular events and SAHS severity

Estimated Enrollment:	700
Study Start Date:	May 2004
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Epworth <10
Apnea-Hypopnea Index ≥20

Exclusion Criteria:

Presence of any chronic disease
Presence of cardiovascular disease
Refusal to sign informed consent
Drug addiction and/or alcoholism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127348

Locations

Spain
Hospital Univ Arnau de Vilanova
Lleida, Catalonia, Spain, 25198

Sponsors and Collaborators

Sociedad Española de Neumología y Cirugía Torácica

Investigators

Principal Investigator:

Ferran Barbe, MD

Hospital Universitari Arnau de Vilanova. Lleida. Spain

More Information

No publications provided by Sociedad Española de Neumología y Cirugía Torácica

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barbé F, Durán-Cantolla J, Capote F, de la Peña M, Chiner E, Masa JF, Gonzalez M, Marín JM, Garcia-Rio F, de Atauri JD, Terán J, Mayos M, Monasterio C, del Campo F, Gomez S, de la Torre MS, Martinez M, Montserrat JM; Spanish Sleep and Breathing Group. Long-term effect of continuous positive airway pressure in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Apr 1;181(7):718-26. Epub 2009 Dec 10.

ClinicalTrials.gov Identifier:	NCT00127348 History of Changes
Other Study ID Numbers:	PI 040165
Study First Received:	August 4, 2005
Last Updated:	April 2, 2007
Health Authority:	Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:

Apnea
Cardiovascular Diseases
Hypertension
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012