Sleep Apnea and Oxidative Stress and Nitric Oxide

Tracking Information
First Submitted Date ICMJE	October 22, 2007
First Posted Date ICMJE	October 23, 2007
Last Update Posted Date	November 9, 2007
Study Start Date ICMJE	May 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: October 22, 2007)	concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma [ Time Frame: 3 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00547937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Sleep Apnea and Oxidative Stress and Nitric Oxide
Official Title ICMJE	Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure
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.
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 Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator)
Condition ICMJE	Sleep Apnea Syndromes
Intervention ICMJE	Device: nasal continuous positive airway pressure (CPAP) therapy; Nocturnal ventilation through a nasal mask to avoid sleep apneas
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 22, 2007)	31
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2003
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Spain
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00547937
Other Study ID Numbers ICMJE	NO-OE-SAHS
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Sociedad Española de Neumología y Cirugía Torácica
Collaborators ICMJE	Fondo de Investigacion Sanitaria
Investigators ICMJE	Principal Investigator: Alberto Alonso, MD Sociedad Española de Neumología y Cirugía Torácica
PRS Account	Sociedad Española de Neumología y Cirugía Torácica
Verification Date	October 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP