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 new long-term study outcomes showed that the improvements observed at one-year were sustained at the three-year follow-up mark. The outcomes include:

  • A 78% reduction in apnea-hypopnea events from baseline (see fig. 1)
  • An 80% reduction in oxygen desaturation events from baseline (see fig. 2)
  • Clinically meaningful improvements and a return to normal levels over baseline in quality of life measures, including daytime sleepiness and functioning as measured by the Epworth Sleepiness Scale (ESS) (see fig. 3) and the Functional Outcomes of Sleep Questionnaire (FOSQ) (see fig. 4)
  • An 80% bed partner reported rate of soft or no snoring, as compared to 17% of bed partners at baseline (see fig. 5)
  • High therapy adherence (see fig. 6)

 

46 Inspire therapy responders were chosen for a randomized controlled therapy withdrawal study between months 12 and 18. In the randomized assessment, those in the therapy withdrawal group returned to baseline AHI/ODI levels as well as baseline quality of life measures, while the therapy maintenance group experienced no change (see fig. 7). At 18-months, both groups showed sustained subjective and objective improvements similar to those observed at 12 months, attributing the worsening of symptoms directly to Inspire therapy withdrawal.

Figure 1. Significant reduction in apnea-hypopnea events

Figure 2

Figure 2. Significant reduction in oxygen desaturation events

Figure 3

Figure 3. Significant improvements in daytime functioning

Figure 4a

Figure 4. Significant improvements in daytime sleepiness and functioningFigure 4b

Figure 5. Partner reported snoring outcomes

Figure 5

Figure 6. Therapy adherence

Figure 6

Figure 7. Confirmation of therapeutic effect

Figure 1

12 Month Data: Strollo et al. NEJM 2014

Randomized Controlled Withdrawal: Woodson et al. OTO-HNS 2014

18 Month Data: Strollo et al. SLEEP 2015

36 Month Data: Woodson et al. OTO-HNS 2015

Adherence Data: STAR database

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