Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS)

Phase 4

Completed

• Conditions: Sleep Apnea; Cardiovascular Diseases
• Interventions: Device: Sham CPAP; Device: nasal CPAP

• Registration Number: NCT00487929
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.

Detailed Description

Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.

Design: randomized, double blind, of parallel groups and controlled with placebo study.

Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23 control subjects.

Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).

Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure, endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of catecholamines.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-18
• Study First Posted: 2007-06-19
• Status Verified: 2008-10
• Primary Completion: 2012-04
• Study Completion: 2012-10
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Sleep apnea-hypopnea syndrome (AHI > 5)
• Excessive sleepiness (ESS > 11)
• No previous CPAP treatment

Exclusion Criteria

• Blood pressure > 180/120 mmHg.
• Secondary hypertension
• Professional driver
• COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease
• Neuromuscular disease or thyroid function abnormalities
• Morbid obesity (BMI > 40 Kg/m2).
• Respiratory infection in the 2 last months.
• Anemia (Hb < 10 g/dl) or polyglobulia (Hct > 55%).
• Diurnal hypercapnia (PaCO2 > 45 mmHg) or moderate hypoxemia (PaO2 < 70 mmHg).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham CPAP	Sham CPAP	Sham nasal continuous positive airway pressure
CPAP	nasal CPAP	Continuous positive airway pressure

Primary Outcome Measures

Name	Time	Method
Plasmatic 8-isoprostane concentration	three months

Secondary Outcome Measures

Name	Time	Method
Plasmatic and condensed exhaled air concentrations of homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites.	three months

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain