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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127348
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : April 4, 2007
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica

Brief Summary:

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 or disease Intervention/treatment Phase
Sleep Apnea Hypertension Cardiovascular Diseases Device: CPAP (Continuous Positive Airway Pressure) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Primary Outcome Measures :
  1. Incidence of hypertension
  2. Incidence of cardiovascular events

Secondary Outcome Measures :
  1. Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
  2. Relationship between cardiovascular events and SAHS severity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127348

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Hospital Univ Arnau de Vilanova
Lleida, Catalonia, Spain, 25198
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
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Principal Investigator: Ferran Barbe, MD Hospital Universitari Arnau de Vilanova. Lleida. Spain
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00127348    
Other Study ID Numbers: PI 040165
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2006
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Disorders of Excessive Somnolence
Cardiovascular Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders