Overview

This trial is active, not recruiting.

Conditions obstructive sleep apnea, vascular stiffness, sleep disorder daytime somnolence
Treatment cpap (resmed s9 autoset)
Sponsor Centro Hospitalar de Lisboa Central
Collaborator Universidade Nova de Lisboa
Start date October 2012
End date September 2016
Trial size 45 participants
Trial identifier NCT02273089, CHLC.CI.105.2014

Summary

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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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)
nocturnal CPAP for three months
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)
nocturnal CPAP for three months

Primary Outcomes

Measure
Aortic pulse wave velocity (PWV)
time frame: Change on PWV from baseline up to three months of intervention

Secondary Outcomes

Measure
Apnea-Hypopnea Index (AHI)
time frame: Change on AHI from baseline up to three months of intervention
Nocturnal oxygenation
time frame: Change from baseline up to three months of intervention
Excessive daytime sleepiness
time frame: Change on ESS from baseline up to three months of intervention

Eligibility Criteria

Male participants from 30 years up to 65 years old.

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

Additional Information

Official title Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP)
Principal investigator Alexandra Mineiro, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centro Hospitalar de Lisboa Central.