CPAP to Reduce Arterial Stiffness in Non Sleepy, Moderate to Severe Obstructive Sleep Apnea (STIFFSLEEP)

Centro Hospitalar de Lisboa Central45 enrolled

Overview

This study intends to determine whether continuous positive airway pressure (CPAP) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea .

Obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity and mortality. Arterial stiffness, evaluated by pulse wave velocity, is related to atherosclerosis and cardiovascular risk. It has been reported that arterial stiffness is higher in patients with OSA than in healthy control groups, and it is assumed that it decreases after treatment with CPAP. In patients with OSA without daytime hypersomnolence it is not clear if CPAP has some benefits on cardiovascular events and hypertension. This study aims to evaluate the effect of CPAP therapy in an interventional cohort of patients with moderate to severe OSA, in which each patient will be is own control, for ethical reasons; the effect of CPAP therapy on the subcohorts of sleepy and of nonsleepy patients will be compared. The effect of a three months trial of CPAP will be assessed.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Apnea Vascular Stiffness Sleep Disorder Daytime Somnolence

Interventions

CPAP (ResMed S9 AutoSet)DEVICE

nocturnal CPAP for three months

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate to severe obstructive sleep apnea, defined as apnea/hypopnea index superior to 15 Exclusion Criteria: * Epworth sleep scale superior to 16 * other sleep diseases * moderate or severe lung disease * cardiac disease other than hypertension * cerebrovascular diseases * other vascular diseases * other chronic diseases except metabolic syndrome

Locations (2)

Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central

Lisbon, Portugal

Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central

Lisbon, Portugal

Outcomes

Primary Outcomes

Aortic pulse wave velocity (PWV)

carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France).

Time frame: Change on PWV from baseline up to three months of intervention

Secondary Outcomes

Apnea-Hypopnea Index (AHI)

AHI is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep, using polygraphic study.

Time frame: Change on AHI from baseline up to three months of intervention

Nocturnal oxygenation

Measure of minimal saturation of oxygen (SO2), time under 90% SO2, average SO2, oxygen desaturation index, using polygraphic study.

Time frame: Change from baseline up to three months of intervention

Excessive daytime sleepiness

Epworth sleep scale (ESS)

Time frame: Change on ESS from baseline up to three months of intervention

Data from ClinicalTrials.gov

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