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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
History of Changes

October 22, 2007
November 7, 2007
May 2001
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concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00547937 on ClinicalTrials.gov Archive Site
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Sleep Apnea and Oxidative Stress and Nitric Oxide
Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure
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.
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Sleep Apnea Syndromes
Device: nasal continuous positive airway pressure (CPAP) therapy
Nocturnal ventilation through a nasal mask to avoid sleep apneas
  • 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
    Intervention: Device: nasal continuous positive airway pressure (CPAP) therapy
  • Active Comparator: CPAP
    Intervention: Device: nasal continuous positive airway pressure (CPAP) therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2003
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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.
Male
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00547937
NO-OE-SAHS
Yes
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Sociedad Española de Neumología y Cirugía Torácica
Fondo de Investigacion Sanitaria
Principal Investigator: Alberto Alonso, MD Sociedad Española de Neumología y Cirugía Torácica
Sociedad Española de Neumología y Cirugía Torácica
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP