NCT00547937

Sleep Apnea and Oxidative Stress and Nitric Oxide

Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sociedad Española de Neumología y Cirugía Torácica · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

Summary

Background: Previous studies present contradictory data concerning obstructive sleep apnea syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma of middle aged males with OSAS and no other known comorbidity and carefully matched healthy controls of the same age and gender; and (2) to test the hypothesis that nasal continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and nitrate deficiency.

Detailed description

We performed a single-center, prospective, randomized, double-blind, placebo-controlled and cross-over clinical study, in which patients received CPAP and sham therapy for two 12-week periods. Baseline measurements in healthy controls matched for age and gender were also obtained. At recruitment, 24-h blood pressure monitoring (ABPM), an echocardiogram (to rule out any cardiac dysfunction) and a sleep study was obtained in all participants . After fasting overnight, a venous blood sample (anti-coagulated with dipotassium EDTA, for 8-isoprostane and total nitrate and nitrite concentration (NOx) determinations) and a urine sample were collected in all of them between 08:00 and 10:00 hours. Within 30 minutes of blood collection, plasma was obtained by centrifugation at 3000 rpm for 15 min. All plasma samples were stored at -60°C until analysis. Patients with OSAS underwent a full-night CPAP titration study using an automated pressure setting device (Auto Set; ResMed, Sydney, Australia). Compliance with therapy was obtained from a built-in run-time counter. After 12 weeks, CPAP device was switched to the alternate mode of therapy and ABPM,, plasma and urine sampling were repeated in patients

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	nasal continuous positive airway pressure (CPAP) therapy	Nocturnal ventilation through a nasal mask to avoid sleep apneas

Timeline

• Start date: 2001-05-01
• Completion: 2003-12-01
• First posted: 2007-10-23
• Last updated: 2007-11-09

Locations

1 site across 1 country: Spain