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

Centro Hospitalar de Lisboa Central

Status: Terminated

Conditions: Vascular Stiffness; Sleep Disorder Daytime Somnolence; Obstructive Sleep Apnea

Treatments: Device: CPAP (ResMed S9 AutoSet)

Study type: Observational

Funder types: Other

Identifiers

NCT02273089

CHLC.CI.105.2014

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 45 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 2 patient groups

OSA w/o EDS

Description:

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

Treatment:

Device: CPAP (ResMed S9 AutoSet)

OSA w EDS

Description:

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

Treatment:

Device: CPAP (ResMed S9 AutoSet)