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Sponsored by: |
Ohio State University |
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Information provided by: | Ohio State University |
ClinicalTrials.gov Identifier: | NCT00701441 |
Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 % of middle aged adults, and is becoming increasingly implicated in the pathogenesis of hypertension, and other cardiovascular disorders. Up to half of patients with OSA have hypertension, and their risk of developing hypertension increases with the increasing severity of Sleep Apnea. Patients with OSA and no hypertension have endothelial dysfunction, which is believed to be the precursor for most cardiovascular disorders. The upper airway collapse, and obstruction that occur in OSA result in a pattern of intermittent hypoxia, that has been shown to be the cause of the hypertension, and endothelial dysfunction found in patients with OSA. Intermittent hypoxia results in oxidative stress, which in turn is linked to the pathogenesis of hypertension and endothelial dysfunction. This protocol evaluates the role of the oxidative stress in endothelial function and blood pressure in patients with OSA. This is a pilot clinical study that will compare oxidative stress parameters, and endothelial function in patients with OSA before and after a two week course of the either one of the antioxidant drugs Allopurinol, and vitamin C. A skin biopsy of the forearm will be done to isolate dermal arterioles, and vascular endothelial cells at baseline and again following the 2 week period. This will enable assessment of the endothelial function. Oxidative stress parameters will be assessed in the plasma by blood draw. The two drugs are widely used with a very reasonable safety profile, specifically for a limited two week course. The skin biopsy is a minimally invasive procedure. Obtaining vascular tissue with the skin biopsy is a pioneering technique that has already lead to significant findings in the field of vascular biology. The area of cardiovascular complications of sleep apnea is in great need for research to understand the mechanisms of the interaction, and provide therapeutic options to a segment of the population exceeding 24% of men, and 9 % of women. Great attention is given to this area by public and governmental organizations such as the NIH.
Condition | Intervention |
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Sleep Apnea |
Dietary Supplement: Vitamin C Device: CPAP Dietary Supplement: Allopurinol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Role of Oxidative Stress in the Cardiovascular Consequences of Sleep Apnea |
Estimated Enrollment: | 70 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: No Intervention | |
OSA Vitamin C: Experimental
Vitamin C given
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Dietary Supplement: Vitamin C
Vitamin C Supplements
Device: CPAP
Usage of CPAP
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OSA Allopurinol: Experimental
Allopurinol given
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Device: CPAP
Usage of CPAP
Dietary Supplement: Allopurinol
Allopurinol given
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OSA Device: Experimental
CPAP therapy only
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Device: CPAP
Usage of CPAP
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Obstructive Sleep Apnea (OSA) is increasingly recognized as an important risk factor for cardiovascular morbidity and mortality (refs). The association between Obstructive Sleep apnea (OSA) and hypertension (HTN) is particularly significant, as hypertension is the most prevalent cardiovascular disease.
The World Health Organization reports that suboptimal BP (>115 mm Hg SBP) is responsible for 62% of cerebrovascular disease and 49% of ischemic heart disease (WHO 2002). OSA affects more than 24% of men and 9% of women in the middle age, and these patients have up to 50% incidence of hypertension. More recent large epidemiological studies have supported a causal relation between OSA and HTN, and identified OSA as an independent risk factor for developing HTN. The pathogenesis of HTN in patients with OSA remains much less understood. OSA is characterized by episodes of upper airway narrowing or closure occurring throughout the sleep period and resulting in a cyclic pattern of increased respiratory effort, intermittent hypoxia, and surges in sympathetic activity, and blood pressure. Both of animal models and human experiments support the conclusion that intermittent hypoxia is the only required stimulus for the hypertensive response seen in animal models of intermittent hypoxia, and sleep apnea. The pattern of hypoxia reoxygenation seen in patients with OSA is characterized by an increase in oxidative stress. In turn, oxidative stress has been clearly implicated in the pathogenesis of hypertension and other cardiovascular disorders. Therefore, evaluation of the impact of modulation of oxidative stress in patients with sleep apnea on blood pressure and endothelial function is believed by the applicant to be an important and natural direction of the work in this area. Findings of this project may provide new therapeutic options for patients with sleep apnea that could reduce their risk of developing cardiovascular disease
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Ohio State University ( Dr. Rami Khayat ) |
Study ID Numbers: | 2005H0221 |
Study First Received: | May 15, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00701441 History of Changes |
Health Authority: | United States: Institutional Review Board |
sleep apnea, oxidative stress |
Antimetabolites Sleep Apnea Syndromes Allopurinol Antioxidants Apnea Respiration Disorders Stress Sleep Disorders Dyssomnias |
Trace Elements Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Vitamins Signs and Symptoms, Respiratory Micronutrients Antirheumatic Agents Ascorbic Acid |
Antimetabolites Allopurinol Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Sleep Disorders Gout Suppressants Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Vitamins Therapeutic Uses Free Radical Scavengers |
Signs and Symptoms, Respiratory Micronutrients Sleep Apnea Syndromes Apnea Growth Substances Nervous System Diseases Respiration Disorders Dyssomnias Enzyme Inhibitors Protective Agents Pharmacologic Actions Antirheumatic Agents Ascorbic Acid |