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| Name | Class |
|---|---|
| Accriva Diagnostics | INDUSTRY |
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Obstructive Sleep Apnea (OSA) patients are at increased risk of major cardiovascular events, so many patients take aspirin for prevention. Poor responsiveness to aspirin is a major clinical concern because it can potentially worsen the prognosis of OSA patients. However, continuous positive airway pressure (CPAP) therapy that is considered standard of care for OSA treatment may potentially lead to improvement in responsiveness to aspirin. This study will determine whether CPAP therapy decreases patients' aspirin resistance in OSA patients with a new diagnosis or existing moderate to severe OSA who are treated with CPAP and take aspirin for prevention.
Obstructive Sleep Apnea (OSA) is a common sleep-related breathing disorder that afflicts more than 25 million adults in the United States. This number continues to rise yearly due to increased incidence of obesity in the United States. The prevalence of OSA among males and females is also on the rise with 34% of males and 17% of females diagnosed with this disease.
OSA is characterized as intermittent pharyngeal soft-tissue obstruction due to anatomical or positional etiology during sleep. This leads to episodes of hypoxemia and apneas which result in overall sleep fragmentation. The pathophysiology associated with OSA is complex. However, some proposed causes of OSA include hypoxia during sleep which causes increased circulating catecholamines and sympathetic activation, free radical formation leading to oxidative stress, increased cytokine release and endothelial dysfunction. These proposed mechanisms are also associated with increased platelet aggregation and hyperactivity and increase a patient's overall risk for cardiovascular morbidities.
Many patients with cardiovascular co-morbidities are taking aspirin for primary or secondary prevention. With a concomitant diagnosis of OSA, it is thought that these patients who are taking aspirin on a daily basis may become resistant to its effects based on how their OSA is controlled (ie. CPAP vs. Non-CPAP). Although aspirin resistance has been noted to be a "laboratory phenomenon," there have been studies which have shown a three-fold increase in cardiovascularco- morbidities in patients who were found to be aspirin resistant. In this study, it is our goal to determine the prevalence of aspirin resistance in patients who have a diagnosis of OSA and undergoing treatment with CPAP or Non-CPAP methods by measuring Aspirin Resistant Units (ARUs) using light aggregometry. It is our overall objective to determine whether or not OSA is an independent risk factor for aspirin resistance.
OSA patients are at increased risk of major cardiovascular events and aspirin resistance is associated with poor cardiovascular outcomes. Studying aspirin responsiveness in OSA patients may help to elucidate the potential role of platelet function testing, including the possible clinical implications of an aspirin therapy regimen guided by platelet function testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - No Obstructive Sleep Apnea with Aspirin | The control group consist of patients with a negative diagnosis of OSA (based on a negative home sleep apnea test (REI) < 5 and attended sleep study, AHI < 5; or attended NPSG with an AHI < 5) and the patient is taking aspirin at a dose of 81 mg/day for at least a week prior to inclusion. After obtaining written informed consent, approximately 6 ml of blood was collected via venipuncture. |
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| Arm 1- Obstructive Sleep Apnea with CPAP therapy and Aspirin | Arm 1 consist of patients with a diagnosis of OSA (based on home or attended sleep study) with an REI/AHI > 15 with or without symptoms or REI/AHI > 5 with symptoms of sleep apnea in a patient 18-85 years old, CPAP has been started within the last 2 years, and patient is taking aspirin at a dose of 81mg/day for at least a week, last dose taken within 24 hours prior to enrollment. After obtaining written informed consent, approximately 6 ml of blood was collected via venipuncture. |
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| Arm 2 -Obstructive Sleep Apnea with no CPAP & Aspirin | Arm 2 consist of patients with a diagnosis of OSA (based on home or attended sleep study) with an REI/AHI > 15 with or without symptoms or REI/AHI > 5 with symptoms of sleep apnea in a patient 18-85 years old and patient is taking aspirin at a dose of 81mg/day for at least a week, last dose taken within 24 hours prior to enrollment. After obtaining written informed consent, approximately 6 ml of blood was collected via venipuncture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin Resistance testing | Other | Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay) |
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| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of aspirin resistance in patients with newly diagnosed OSA taking aspirin for primary or secondary prevention. | The prevalence of aspirin resistance, measured by platelet aggregometry, in patients with newly diagnosed OSA who take aspirin for primary or secondary prevention. | Immediately after consent is obtained (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of aspirin resistance in OSA patients who take aspirin for primary or secondary prevention and are currently being treated with CPAP. | The prevalence of aspirin resistance in those patients with OSA on aspirin for primary or secondary prevention who are currently being treated with CPAP. | Immediately after consent is obtained (baseline) |
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Inclusion Criteria for Control Group:
Inclusion Criteria for "CPAP-Naïve" Cohort:
Inclusion Criteria for "CPAP-treated" Cohort:
Exclusion Criteria for all cohorts including control group:
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Patients who come to the WCHN Pulmonary and Sleep Medicine Clinic either for a follow-up appointment to monitor their therapy for OSA or for an appointment to discuss a new diagnosis of OSA referred by their pulmonologist.
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| Name | Affiliation | Role |
|---|---|---|
| Jose L Mendez | Nuvance Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23589584 | Background | Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14. | |
| 23910433 | Background | Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 20032579 | Background | Oga T, Chin K, Tabuchi A, Kawato M, Morimoto T, Takahashi K, Handa T, Takahashi K, Taniguchi R, Kondo H, Mishima M, Kita T, Horiuchi H. Effects of obstructive sleep apnea with intermittent hypoxia on platelet aggregability. J Atheroscler Thromb. 2009;16(6):862-9. doi: 10.5551/jat.2188. Epub 2009 Dec 22. |
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| 26573589 | Background | Cai G, Zhou W, Lu Y, Chen P, Lu Z, Fu Y. Aspirin resistance and other aspirin-related concerns. Neurol Sci. 2016 Feb;37(2):181-9. doi: 10.1007/s10072-015-2412-x. Epub 2015 Nov 14. |
| 12651041 | Background | Gum PA, Kottke-Marchant K, Welsh PA, White J, Topol EJ. A prospective, blinded determination of the natural history of aspirin resistance among stable patients with cardiovascular disease. J Am Coll Cardiol. 2003 Mar 19;41(6):961-5. doi: 10.1016/s0735-1097(02)03014-0. |
| 15989905 | Background | Lee PY, Chen WH, Ng W, Cheng X, Kwok JY, Tse HF, Lau CP. Low-dose aspirin increases aspirin resistance in patients with coronary artery disease. Am J Med. 2005 Jul;118(7):723-7. doi: 10.1016/j.amjmed.2005.03.041. |
| 22740110 | Background | Grinstein J, Cannon CP. Aspirin resistance: current status and role of tailored therapy. Clin Cardiol. 2012 Nov;35(11):673-81. doi: 10.1002/clc.22031. Epub 2012 Jun 27. |
| 17489881 | Background | Cheng G, Shan J, Xu G, Liu P, Zhou Y, Zhu Y, Lu X. Relationship between endothelial dysfunction, oxidant stress and aspirin resistance in patients with stable coronary heart disease. J Clin Pharm Ther. 2007 Jun;32(3):287-92. doi: 10.1111/j.1365-2710.2007.00823.x. |
| 26654519 | Background | Hopps E, Caimi G. Obstructive Sleep Apnea Syndrome: Links Betwen Pathophysiology and Cardiovascular Complications. Clin Invest Med. 2015 Dec 4;38(6):E362-70. doi: 10.25011/cim.v38i6.26199. |
| 22618923 | Background | Barbe F, Duran-Cantolla J, Sanchez-de-la-Torre M, Martinez-Alonso M, Carmona C, Barcelo A, Chiner E, Masa JF, Gonzalez M, Marin JM, Garcia-Rio F, Diaz de Atauri J, Teran J, Mayos M, de la Pena M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366. |
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| 25126033 | Background | Sokucu SN, Ozdemir C, Dalar L, Karasulu L, Aydin S, Altin S. Complete blood count alterations after six months of continuous positive airway pressure treatment in patients with severe obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):873-8. doi: 10.5664/jcsm.3958. |
| 21591980 | Background | Varol E, Ozturk O, Yucel H, Gonca T, Has M, Dogan A, Akkaya A. The effects of continuous positive airway pressure therapy on mean platelet volume in patients with obstructive sleep apnea. Platelets. 2011;22(7):552-6. doi: 10.3109/09537104.2011.578182. Epub 2011 May 19. |
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| 21509427 | Background | Ozben S, Ozben B, Tanrikulu AM, Ozer F, Ozben T. Aspirin resistance in patients with acute ischemic stroke. J Neurol. 2011 Nov;258(11):1979-86. doi: 10.1007/s00415-011-6052-7. Epub 2011 Apr 21. |
| 28100965 | Background | Pasala T, Hoo JS, Lockhart MK, Waheed R, Sengodan P, Alexander J, Gandhi S. Aspirin Resistance Predicts Adverse Cardiovascular Events in Patients with Symptomatic Peripheral Artery Disease. Tex Heart Inst J. 2016 Dec 1;43(6):482-487. doi: 10.14503/THIJ-14-4986. eCollection 2016 Dec. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |