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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP)

Conditions
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Obstructive Sleep Apnea, Vascular Stiffness, Sleep Disorder Daytime Somnolence

Intervention / Treatment
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* Device: CPAP (ResMed S9 AutoSet)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA w/o EDS<br>Males with moderate to severe obstructive sleep apnea without excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months | Device: CPAP (ResMed S9 AutoSet)<br>* nocturnal CPAP for three months<br>|
| OSA w EDS<br>Males with moderate to severe obstructive sleep apnea with excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months | Device: CPAP (ResMed S9 AutoSet)<br>* nocturnal CPAP for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic pulse wave velocity (PWV) | carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France). | Change on PWV from baseline up to three months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from baseline up to three months of intervention | 
| Excessive daytime sleepiness | Epworth sleep scale (ESS) | Change on ESS from baseline up to three months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, arterial stiffness, CPAP, excessive daytime sleepiness, pulse wave velocity