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Sleep Apnea and Oxidative Stress and Nitric Oxide

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ClinicalTrials.gov Identifier: NCT00547937
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : November 9, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: nasal continuous positive airway pressure (CPAP) therapy Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure
Study Start Date : May 2001
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547937

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

ClinicalTrials.gov Identifier: NCT00547937     History of Changes
Other Study ID Numbers: NO-OE-SAHS
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: November 9, 2007
Last Verified: October 2007

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
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents