The burden of both objective and subjective obstructive sleep apnea (OSA) improved more in patients who received upper airway stimulation (UAS) compared with those who did not, according to results of an analysis published in Annals of the American Thoracic Society.
Investigators conducted a prospective, parallel-arm, multinational, experimental study (ClinicalTrials.gov Identifier: NCT02907398) to compare OSA measures and patient-reported outcomes in individuals who received approval for UAS (n=230; therapy arm) vs those who received an insurance denial (n=100; no-therapy arm or comparator arm). The study was conducted at 9 academic medical centers — 6 in the United States and 3 in Germany — between October 2017 and January 2019.
The primary study end point was posttreatment apnea hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) at final follow-up in both the therapy and the comparator arms. Secondary end points included a comparison of the Functional Outcomes of Sleep Questionnaire (FOSQ-10) and Clinical Global Impression between the 2 groups at the final visit.
All participants needed to meet the criteria for UAS implantation: OSA with preoperative AHI of 15 to 65 events per hour and <25% central and mixed apneas, continuous positive airway pressure (CPAP) intolerance, and the absence of complete concentric collapse at the soft palate while undergoing a drug-induced sleep endoscopy. Baseline data included participants’ demographics, medical history, OSA treatment history, AHI, and ESS.
Individuals in the UAS treatment group experienced a statistically significant greater reduction in AHI from baseline compared with those in the comparator group (-19.1±15.8 vs -8.1±20.9; P <.001). Further, at the final visit, measures of hypoxia (ie, oxygen desaturation index 4% and nadir oxygen saturation) had significantly improved in the therapy group vs the no-therapy group (P <.001 and P =.02, respectively).
Women and those with prior oral appliance use had a lower odds of insurance approval (odds ratio [OR], 0.40; 95% CI, 0.22-0.71 and OR, 0.35; 95% CI, 0.18-0.69, respectively) compared with men and those who had not previously used an oral appliance.
The investigators concluded that the study results highlight the need to enhance clinical care pathways that are focused on the effective treatment of patients with OSA who are not eligible for UAS with insurance and to prioritize public health policy initiatives to address insurance-based sex-specific inequalities.
Disclosure: This clinical trial was supported by Inspire Medical Systems. Please see the original reference for a full list of authors’ disclosures.
Mehra R, Steffen A, Heiser C, et al; on behalf of the ADHERE Registry Study. Upper airway stimulation versus untreated comparators in positive airway pressure treatment refractory obstructive sleep apnea. Ann Am Thorac Soc. Published online July 14, 2020. doi:10.1513/AnnalsATS.202001-015OC