Not Signed In -
Daytime sleepiness |
|
|
Clinical Trial: Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients with Sleep Apnea and No Daytime Sleepiness
This study is currently recruiting patients.
Verified by Spanish Society of Pneumology and Thoracic Surgery June 2005
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 |
|---|---|
| Sleep Apnea Hypertension Cardiovascular Diseases | Device: CPAP (Continuous Positive Airway Pressure) |
MedlinePlus related topics: Heart Diseases; High Blood Pressure; Sleep Apnea; Vascular Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients with Sleep Apnea and Without Daytime Sleepiness
Secondary Outcomes: Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity; Relationship between cardiovascular events and SAHS severity
Expected Total Enrollment: 700
Study start: May 2004; Expected completion: December 2008
Last follow-up: August 2005; Data entry closure: December 2005
Eligibility
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
Location and Contact Information
Spain, Islas Baleares
Hospital Son Dureta, Palma de Mallorca, Islas Baleares, 07014, Spain; Recruiting
Ferran Barbe, MD, Principal Investigator
Ferran Barbe, MD, Principal Investigator, Hospital Universitario Son Dureta. Palma de Mallorca. Spain.
More Information
Last Updated: August 22, 2005
Record first received: August 4, 2005
ClinicalTrials.gov Identifier: NCT00127348
Health Authority: Spain: Ministry of Health and Consumption
ClinicalTrials.gov processed this record on 2005-08-23
email this page
print this page
bookmark this page
feedback on this page
