Sleep Apnea-Patient Centered Outcomes Network (SA-PCON)
Susan Redline, MD, MPH
American Sleep Apnea Association
Patient-Powered Research Networks
District of Columbia
Executive Summary: Breathing and sleep are both essential to life. Unfortunately, millions of adults and children suffer from sleep apnea, which causes nightly, recurrent interruptions of breathing during sleep due to collapse of the tissues in the throat.1 Sleep apnea deprives individuals of oxygen during sleep, and results in sympathetic nervous system over-activity, profound blood pressure surges, and sleep disruption. The immediate sequelae of sleep apnea and hypoxemia cascade into life-threatening health problems with major public health impact. The consequences range from sleepiness, depression, and impaired quality of life to hypertension, myocardial infarction, stroke, diabetes, and early mortality.2-9 Sleep apnea affects 17% of adults and 1-4% of children,10 with rates increasing in association with the obesity epidemic.11 Sleep apnea aggregates in families,12 affects all age groups, and disproportionately affects minorities13 and those from poor neighborhoods.14
Though much has been learned about the epidemiology and pathophysiology of sleep apnea, management of the disease is disjointed and often suboptimal. Minority and disadvantaged groups are at increased risk for sleep apnea,13 yet are less likely to receive effective treatment.15 Use of diagnostic tests (home- or lab-based sleep studies) is more often influenced by the patient's insurance than by clinical factors. Treatments include positive airway pressure (PAP), mandibular advancement devices, various surgeries, and behavioral interventions. However, there is little data to inform which treatments, or combinations of treatments, work best in given patients.16 Treatment strategies often reflect which specialist (e.g., pulmonologist, ENT, etc.) the patient sees rather than his or her clinical presentation or preferences. Traditionally, treatment has focused on improving a number—the Apnea Hypopnea Index—rather than improving patient-centered outcomes such as quality of life. Achieving optimal adherence to treatments such as PAP is a challenge.17 Efforts heretofore to develop strategies for improving adherence have not involved the patient; furthermore, minimizing treatment burden is not routinely considered. Behavioral approaches including modifying diet, physical exercise, and sleep position are not often systematically addressed. The sleep apnea patient is left to his or her own devices to find relief, which is particularly troubling for poor and minority patients with fewer resources. Thus, the Sleep Apnea Patient-Centered Outcomes Network (SAPCON) proposes to address the dual need to conduct critically important comparative effectiveness research while actively engaging patients and other key stakeholders in every aspect of research and implementation by participating as a PCORI Patient-Powered Research Network (PPRN). Patients (including children via caregivers), particularly minorities and the medically underserved, will be given a voice in directing sleep apnea research that focuses on outcomes that matter to them.
The SAPCON represents an exciting collaboration of the American Sleep Apnea Association (ASAA), the nation's sole sleep apnea patient-centric organization, which serves as an information clearinghouse and support network for people who suffer with sleep apnea and their loved ones, with major research and clinical partners that include Harvard's Brigham and Women's Hospital; Informatics for Integrating Biology & the Bedside (i2b2)/Shared Health Research Informatics Network (SHRINE); and the Centers for Translational Science Award (CTSA) Sleep Research Network (SRN). Already, novel collaborations have been initiated with other PPRN and CDRN applicants, with plans for co-development of informatics tools and infrastructure and for co-enrollment. The team has the talent and resources needed to efficiently build a PPRN of actively engaged patients and to collect and share health information needed to support critically needed research. Over an 18-month period, 50,000 patients will be recruited from a pool of over 10 million patients, using a broad strategy including social media and targeted clinic-based recruitment. A patient-friendly web portal will be built using open-source and robust tools that will provide each patient a "dashboard" for contributing health information, coupled with powerful visualization and aggregation tools for viewing and monitoring data. "Blue button" technology under development by our partners (national leaders in health exchange information) will be leveraged to rapidly deploy a standardized, interoperable, and scalable network model using the same standards of clinical data exchange already required by federal regulation to support patients in gaining access to and controlling flows of their health information.
In summary, the SAPCON will contribute significantly to PCORI's goals by mobilizing large numbers of patients with a common disease that has a large impact on patient outcomes. It will bring patients and their families from across the United States together, linking them to one another, researchers, and clinicians to identify those questions regarding screening, prevention, and management most relevant to patients. It will also create a centralized, easily accessible web portal for contributing, exchanging, aggregating, viewing, and analyzing data to support comparative effectiveness research within PCORI's National Research Network.
- Luyster FS, Strollo PJ, Jr., Zee PC, Walsh JK. Sleep: a health imperative. Sleep 2012;35:727-34.
- Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. American J Resp Crit Care Med 2010;182:269-77.
- Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart
disease and heart failure: the sleep heart health study. Circulation 2010;122:352 60.
- Punjabi NM, Caffo BS, Goodwin JL, Gottlieb DJ, Newman AB, O'Connor GT, Rapoport DM, Redline S, Resnick HE, Robbins JA, Shahar E, Unruh ML, Samet JM. Sleep-disordered breathing and mortality: a
prospective cohort study. PLoS Med 2009;6:e1000132.
- Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll
- Mehra R, Stone KL, Varosy PD, Hoffman AR, Marcus GM, Blackwell T, Ibrahim OA, Salem R, Redline
S. Nocturnal Arrhythmias across a spectrum of obstructive and central sleep-disordered breathing in older men: outcomes of sleep disorders in older men (MrOS sleep) study. Arch Intern Med 2009;169:1147-55.
- Seicean S, Kirchner HL, Gottlieb DJ, Punjabi NM, Resnick H, Sanders M, Budhiraja R, Singer M, Redline S. Sleep-disordered breathing and impaired glucose metabolism in normal-weight and overweight/obese individuals: the Sleep Heart Health Study. Diabetes Care 2008;31:1001-6.
- Rosen CL, Palermo TM, Larkin EK, Redline S. Health-related quality of life and sleep-disordered breathing in children. Sleep 2002;25:657-66.
- Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Walsleben JA, Redline S. The association of sleep- disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep 2001;24:96-105.
- Rosen CL, Larkin EK, Kirchner HL, Emancipator JL, Bivins SF, Surovec SA, Martin RJ, Redline S. Prevalence and risk factors for sleep-disordered breathing in 8- to 11-year-old children: association with race and prematurity. J Pediatr 2003;142:383-9.
- Young T, Evans L, Finn L, Palta M. Estimation of the Clinically Diagnosed Proportion of Sleep Apnea Syndrome in Middle-aged Men and Women. Sleep 1997;20:705-6.
- Redline S, Tishler PV, Tosteson TD, Williamson J, Kump K, Browner I, Ferrette V, Krejci P. The familial
aggregation of obstructive sleep apnea. American J Crit Care Med 1995;151:682-7.
- Redline S, Tishler PV, Hans MG, Tosteson TD, Strohl KP, Spry K. Racial differences in sleep- disordered breathing in African-Americans and Caucasians. American J Crit Care Med 1997;155:186-92.
- Spilsbury J, Storfer-Isser A, Kirchner HL, Nelson L, Rosen CL, Drotar D, Redline S. Neighborhood Disadvantage as a Risk Factor for Pediatric Obstructive Sleep Apnea. J Pediatrics 2006;149:324-7.
- Billings ME, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Redline S, Rosen CL, Zee P, Kapur VK.
Race and residential socioeconomics as predictors of CPAP adherence. Sleep 2011;34:1653-8.
- Weinstock T, Redline S. Comparative effectiveness research in obstructive sleep apnea: bridging gaps between efficacy studies and clinical practice. . J Comparative Effectiveness Research 2012;1.
- Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to
effective treatment. Proceedings of the American Thoracic Society 2008;5:173-8.