STAR Clinical Trial for Inspire Therapy

The Stimulation Therapy for Apnea Reduction (STAR) clinical trial began in 2010 at 22 leading medical centers across the United States and Europe. One-year STAR Trial outcome measures were published in the January 9, 2014 version of the New England Journal of Medicine. Results showed that sleep apnea patients receiving Inspire therapy experienced significant reductions in sleep apnea events and significant improvements in quality of life measures. Additionally, the overall rate of serious adverse events was < 2%.

 

The significant improvements and reductions measured after 1-year were sustained over a 5-year follow-up period. The outcomes include:

  • 79% reduction in apnea-hypopnea events from baseline (Figure 1)
  • Significant improvements daytime functioning, as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ) (Figure 2)
  • Significant reductions in daytime sleepiness, as measured by the Epworth Sleepiness Scale (ESS) (Figure 3)
  • 90% of bed partners reported soft or no snoring for their partner using Inspire, as compared to only 17% of bed partners at baseline (Figure 4)

Figure 1. Significant reduction in apnea-hypopnea events

Figure 2. Significant improvements in daytime functioning

Figure 3. Significant reductions in daytime sleepiness

Figure 4. Significant reduction in bed partner reported snoring

1-year STAR data: Strollo et al., NEJM 2014

3-year STAR data: Woodson et al., OTO-HNS 2015

5-year STAT data: Woodson et al., OTO-HNS 2018

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