Sleep Apnea and Oxidative Stress and Nitric Oxide

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00547937
First received: October 22, 2007
Last updated: November 7, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Sleep Apnea Syndromes
Device: nasal continuous positive airway pressure (CPAP) therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma [ Time Frame: 3 months ]

Enrollment: 31
Study Start Date: May 2001
Study Completion Date: December 2003
Arms Assigned Interventions
Sham Comparator: Sham-CPAP
The sham CPAP device consisted of a conventional CPAP device, in which the area of the exhalation port was amplified, thereby nearly cancelling nasal pressure; an orifice resistor was connected between the tubing and the CPAP unit that loads the blower with the same airflow resistance as in effective CPAP
Device: nasal continuous positive airway pressure (CPAP) therapy
Nocturnal ventilation through a nasal mask to avoid sleep apneas
Active Comparator: CPAP Device: nasal continuous positive airway pressure (CPAP) therapy
Nocturnal ventilation through a nasal mask to avoid sleep apneas

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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • apnea-hypopnea index (AHI) ≥10 h-1
  • excessive daytime sleepiness defined by an Epworth scale score ≥11 points
  • no treatment for OSAS. Inclusion criteria for healthy control subjects were AHI <5 h-1 and Epworth sleepiness scale <10.

Exclusion Criteria:

  • unwillingness or inability to participate in the study
  • obstructive or restrictive lung disease as identified by pulmonary function testing
  • use of cardioactive drugs
  • cardiac rhythm disturbances, including sinus bradycardia and sinus tachycardia
  • known arterial hypertension, or 24-hour mean blood pressure of 135 and/or 85 mm Hg or more
  • left ventricular ejection fraction <50%, ischemic or valve heart disease, hypertrophic, restrictive or infiltrative cardiomyopathy, pericardial disease or stroke, by history, physical examination, ECG, chest radiography, conventional exercise stress testing, and echocardiography
  • diabetes mellitus, by history or 2 random blood glucose levels ≥126 mg/dl
  • morbid obesity (body mass index >40 Kg/m2)
  • daytime hypoxemia (PaO2 <70 mm Hg) or hypercapnia (PaCO2 >45 mm Hg)
  • need to change medication
  • hospital admission for 10 or more days
  • average nightly CPAP usage less than 3.5 hours.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00547937

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Alberto Alonso, MD Sociedad Española de Neumología y Cirugía Torácica
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00547937     History of Changes
Other Study ID Numbers: NO-OE-SAHS
Study First Received: October 22, 2007
Last Updated: November 7, 2007
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Sleep Apnea
Oxidative Stress
Nitric oxide
Cardiovascular disease

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014