Upper airway stimulation improves patient outcome among patients with moderate to severe OSA – Results from a prospective parallel trial

Upper airway stimulation (UAS) is an effective therapy for obstructive sleep apnea (OSA) patients who cannot adhere to CPAP. This study enrolled patients who met UAS selection criteria with two parallel arms: one group receiving UAS and a second group not receiving UAS due to insurance coverage denial.

The study enrolled participants who met UAS indications of AHI 15 – 65, BMI ≤35. Prospectively, after UAS therapy titration, we collected AHI and patient reported outcome using the Epworth sleepiness scale (ESS) and Functional Outcome of Sleep Questionnaire (FOSQ-10); for the control arm, after insurance denied therapy coverage, we collected the same set of outcome variables.

As of October 2018, the study enrolled 246 participants in the UAS arm, and 58 in the control arm. The two arms had similar age (p = 0.43) and body mass index (p = 0.07). There was a higher proportion of males in the UAS arm than the control arm (p = 0.02). Both arms had similar follow-up duration after enrollment (308 ± 141 days vs. 287 ± 279, p = 0.62).

Baseline AHI and ESS were similar in both groups. The UAS arm had a larger post-operative AHI decrease of -21.2 ± 16.5 events/hour than the control arm decrease of -9.9 ± 16.4 events/hour (p < 0.001). UAS therapy usage was 6.5 ± 1.9 hours/night. The UAS arm had a significant improvement in ESS after therapy, and the control arm ESS worsened without treatment. Additionally, using FOSQ-10, the UAS arm had larger normalization of functional status than the control arm.

In this prospective study, we showed that UAS reduced OSA severity and improved quality of life measures compared with a control group of participants with moderate to severe OSA and met UAS eligibility criteria, but did not receive treatment due to insurance coverage denial.

Publication History

Publication Date:
23 April 2019 (online)