Abstract
Background: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. Methods: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. Results: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was −15.5 (95% CI −18.3 to −12.8), for ESS it was −3.3 (95% CI −4.4 to −2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. Conclusions: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.
Highlights
Obstructive sleep apnea (OSA) is a common and under-recognized disease in western industrialized countries
A total of 89 participants were assessed for eligibility and randomized between December
After the baseline visit with therapy, 45 participants were randomized to the Stim–Sham group and 44 participants to the Sham–Stim group
Summary
Obstructive sleep apnea (OSA) is a common and under-recognized disease in western industrialized countries. In the United States, the estimated prevalence of moderate-tosevere OSA in those 30–70 years old is 6% in women and 13% in men [1]. In the HypnoLaus study from Switzerland, Heinzer et al reported mild OSA in nearly 40% of men under 4.0/). The Wisconsin Sleep Cohort Study, established over two decades ago, demonstrated a relationship between OSA and obesity, as obesity increases globally, the incidence of OSA is expected to increase as well [3]. The standard treatment for OSA is continuous positive airway pressure (CPAP), which is effective but fraught with challenges of maintaining adherence [4]. Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms
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