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OpenTrials
Completed

NCT Number: NCT00127348

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

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Key information

Conditions

Sleep Apnea Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Univ Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP (continuous positive airway pressure)

Device

Primary outcomes

  1. Incidence of hypertension

  2. Incidence of cardiovascular events

Secondary outcomes

  1. Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity

  2. Relationship between cardiovascular events and SAHS severity

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Aug 5, 2005
Registry last updated
Apr 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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