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.
Sponsor:
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00127348
First received: August 4, 2005
Last updated: April 2, 2007
Last verified: April 2006

August 4, 2005
April 2, 2007
May 2004
Not Provided
  • Incidence of hypertension
  • Incidence of cardiovascular events
  • Incidence of hypertension.
  • Incidence of cardiovascular events.
Complete list of historical versions of study NCT00127348 on ClinicalTrials.gov Archive Site
  • Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
  • Relationship between cardiovascular events and SAHS severity
  • Relationship between hypertension and SAHS severity.
  • Relationship between cardiovascular events and SAHS severity.
Not Provided
Not Provided
 
Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sleep Apnea
  • Hypertension
  • Cardiovascular Diseases
Device: CPAP (Continuous Positive Airway Pressure)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
April 2006
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00127348
PI 040165
Not Provided
Not Provided
Sociedad Española de Neumología y Cirugía Torácica
Not Provided
Principal Investigator: Ferran Barbe, MD Hospital Universitari Arnau de Vilanova. Lleida. Spain
Sociedad Española de Neumología y Cirugía Torácica
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP