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

Phase 4 Study of the Relationship Between the Oxidative Stress and the Development of Cardiovascular Complications in the Sleep Apnea-hypopnea Syndrome (SAHS). Effect of the Treatment With CPAP

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487929

Acronym

OSCAMSA

Enrollment

100

Registered

2007-06-19

Start date

2007-06-30

Completion date

2012-10-31

Last updated

2013-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Cardiovascular Diseases

Keywords

sleep apnea, morbidity, cardiovascular, cpap, oxidative stress

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.

Interventions

DEVICEnasal CPAP

Nocturnal

DEVICESham CPAP

Nocturnal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
Plasmatic 8-isoprostane concentration	three months

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026