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Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure Treatment-Refractory Obstructive
Reena Mehra1, Armin Steffen2, Clemens Heiser3
1Department of Otolaryngology and Department of Sleep Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.
Annals of the American Thoracic Society
|July 15, 2020
Summary
Upper airway stimulation significantly improved sleep apnea outcomes compared to no treatment. Insurance approval impacts treatment access and outcomes, highlighting disparities for women and oral appliance users.
Area of Science:
- Sleep Medicine
- Medical Devices
- Health Policy
Background:
- Obstructive sleep apnea (OSA) significantly impacts patient health and quality of life.
- Upper airway stimulation (UAS) offers a treatment alternative for OSA patients.
- Insurance coverage is a critical factor influencing patient access to UAS therapy.
Purpose of the Study:
- To evaluate the impact of insurance coverage on OSA outcomes in patients seeking UAS.
- To compare the natural history of OSA outcomes between patients receiving UAS and those denied insurance coverage.
Main Methods:
- A multinational prospective study (NCT02907398) employed a parallel-arm design.
- Objective sleep apnea measures (e.g., apnea-hypopnea index) and patient-reported outcomes were compared.
- Statistical analyses included Wilcoxon rank-sum tests and logistic regression.
Main Results:
- Patients receiving UAS showed a significantly greater reduction in apnea-hypopnea index (-19.1 vs. -8.1, P < 0.001) and improved nocturnal hypoxia.
- Subjective improvements in dozing propensity (Epworth Score: -5.1 vs. 1.8, P < 0.001) and overall sleep quality were greater with UAS.
- Lower odds of insurance approval were observed for women (OR, 0.40) and prior oral appliance users (OR, 0.35).
Conclusions:
- Upper airway stimulation leads to significant improvements in both objective and subjective sleep apnea burden.
- Findings emphasize the need for optimized care pathways for patients denied UAS and policy initiatives to address insurance-related disparities.
- Sex-specific disparities in insurance approval warrant further investigation and intervention.
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