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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-06-30

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 .

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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.

Conditions

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Obstructive Sleep Apnea Vascular Stiffness Sleep Disorder Daytime Somnolence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA w/o EDS

Males with moderate to severe obstructive sleep apnea without excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months

CPAP (ResMed S9 AutoSet)

Intervention Type DEVICE

nocturnal CPAP for three months

OSA w EDS

Males with moderate to severe obstructive sleep apnea with excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months

CPAP (ResMed S9 AutoSet)

Intervention Type DEVICE

nocturnal CPAP for three months

Interventions

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CPAP (ResMed S9 AutoSet)

nocturnal CPAP for three months

Intervention Type DEVICE

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No