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

April 1, 2013 updated by: Hospital Universitario La Paz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP
Continuous positive airway pressure
Device: nasal CPAP
Nocturnal
Sham Comparator: Sham CPAP
Sham nasal continuous positive airway pressure
Device: Sham CPAP
Nocturnal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasmatic 8-isoprostane concentration
Time Frame: three months
three months

Secondary Outcome Measures

Outcome 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.
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Investigators

  • Study Chair: Francisco García-Rio, PhD, Servicio de Neumología. Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 19, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP051937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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