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
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Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
Tracking Information | ||||
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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 |
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) |
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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 |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
31 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | December 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |