Title: Structured interviews of Lived ExperiencE in Patients (SLEEP study) Obstructive Sleep Apnea and Central Sleep Apnea

Technology of Interest: Positive Air Pressure, PAP Therapy

Disease Area: Respiratory

Duration: 9 months

Network Collaborator(s): HealthCore; PEDSnet

The objective of this Test-Case is to conduct a prospective study of patient-reported outcomes (PROs), patient preferences, and patient experiences to gather patient-generated data (PGD) from patients with Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA) from four populations – adolescents (12—18), young adults (19 – 45), adults (45—65) and seniors (over 65) through semi-structured patient interviews.

OSA is a common medical condition characterized by the periodic collapse of the soft palate and tongue during sleep. While less common, CSA is a disorder in which breathing repeatedly stops and starts during sleep due to improper signals to the muscles controlling breathing.  These periods of temporary restriction where air is restricted are called apneas.  Over 20 million adults in the United States have OSA, and the prevalence is steadily rising as a result of an increasingly obese population across all age groups.  Left untreated, OSA has been associated with obesity, heart disease, hypertension, and diabetes among a host of negative health outcomes.  The primary treatment is positive airway pressure (PAP) therapy, which maintains an open airway via a pneumatic splint.

The study will aim to identify patients’ preferences related to the benefits, challenges, risks, and side effects perceived when utilizing PAP management of OSA and CSA.  Additionally, the study will assess PAP design or delivery characteristics that patients’ perceive would potentially benefit them the most to improve therapy.  Finally, the study will assess patients’, parents’/caregivers’ willingness to engage in such activities as PAP design, regulatory approval process, post-market device evaluations, and the collection patient-generated data for safety and efficacy surveillance and coverage decisions.

The ability to work with both HealthCore researchers and PEDSnet University of Colorado researchers as NESTcc Network Collaborators, with their access to administrative claims data and pediatric populations identified through electronic health records (EHR) data, respectively, is key benefit to working with NESTcc and its Data Network.

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Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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