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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

Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00127348
Enrollment
700
Registered
2005-08-05
Start date
2004-05-31
Completion date
2006-04-30
Last updated
2007-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Hypertension, Sleep Apnea

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.

Interventions

Sponsors

Sociedad Española de Neumología y Cirugía Torácica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Incidence of hypertension
Incidence of cardiovascular events

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026