Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
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|ClinicalTrials.gov Identifier: NCT00127348|
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : April 4, 2007
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||April 2006|
- Incidence of hypertension
- Incidence of cardiovascular events
- Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
- Relationship between cardiovascular events and SAHS severity
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 ClinicalTrials.gov identifier (NCT number): NCT00127348
|Hospital Univ Arnau de Vilanova|
|Lleida, Catalonia, Spain, 25198|
|Principal Investigator:||Ferran Barbe, MD||Hospital Universitari Arnau de Vilanova. Lleida. Spain|