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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT00487929
First received: June 18, 2007
Last updated: April 1, 2013
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Cardiovascular Diseases
 Device: nasal CPAP
Device: Sham CPAP
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Hospital Universitario La Paz:

Primary Outcome Measures:
  • Plasmatic 8-isoprostane concentration [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2007
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP
Continuous positive airway pressure
 Device: nasal CPAP
Nocturnal
Sham Comparator: Sham CPAP
Sham nasal continuous positive airway pressure
 Device: Sham CPAP
Nocturnal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487929

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
Study Chair: Francisco García-Rio, PhD Servicio de Neumología. Hospital Universitario La Paz
  More Information

No publications provided

Responsible Party: Francisco Garcia-Rio, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT00487929     History of Changes
Other Study ID Numbers: HULP051937
Study First Received: June 18, 2007
Last Updated: April 1, 2013
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Hospital Universitario La Paz:
sleep apnea
morbidity
cardiovascular
cpap
oxidative stress

Additional relevant MeSH terms:
Apnea
Cardiovascular Diseases
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013