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    Mrs. Burcu Avci
    (Team lead Medical Support)

    Your contact to Inspire: Burcu Avci

    Mrs. Burcu Avci
    (Team lead Medical Support)

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The clinical trial at a glance

The STAR Study (STAR: Stimulation Therapy for Apnea Reduction) was conducted at 22 leading medical institutions in the United States and Europe. The results of the STAR study were published in the New England Journal of Medicine in the 9 January 2014 issue.1

The results show that patients with Inspire therapy had significantly fewer episodes of apnoea – they also experienced an improvement in quality of life. The rate of serious complications was less than two percent.1

The long-term results published in the meantime show that the improvements reported after 12 months are also consistent after 36 months and 60 months. These include:1-3

  • A 78 % reduction in apnoea-hypopnoea events (see figure 1).
  • A reduction in O2 desaturation events by 80 % (see figure 2).
  • Clinically significant and normalised improvement in sleep-related quality of life, including daytime sleepiness and daytime activity as measured by the Epworth Sleepiness Scale (ESS, see figure 3) and the Functional Outcomes of Sleep Questionnaire (FOSQ, see figure 4), respectively.
  • An increase in the proportion of bed partners reporting no or light snoring to 80%, up from 17% before treatment (see figure 5).
  • High therapy adherence (see figure 6).

For a randomised controlled treatment withdrawal trial, 46 responders from the STAR study were assigned to two groups between months 12 and 18. In the randomised trial, patients in the therapy withdrawal group showed a worsening of the AHI or ODI as well as a worsening of quality of life. The values corresponded to the baseline level before the start of treatment.4

Patients in the continued therapy group, on the other hand, did not experience any changes during the observation period (see figure 7). After 18 months, both groups again showed consistent, subjective and objective therapeutic success. The deteriorations in the therapy withdrawal group can thus be directly attributed to the withdrawal of Inspire therapy.4

Figure 1: Significant reduction of apnoea-hypopnoea events1-3

Figure 1: Significant reduction of apnoea-hypopnoea events

Figure 2: Significant reduction of O2 desaturation events1-3

Figure 2: Significant reduction of O2 desaturation events

Figure 3: Significant improvement in daily activity1-3

Figure 3: Significant improvement in daily activity

Figure 4: Significant improvement in daytime sleepiness1-3

Figure 4: Significant improvement in daytime sleepiness

Figure 5: Bed partner reported snoring1-3

Figure 5: Bed partner reported snoring

Figure 6: Patient-reported treatment adherence1-3

Figure 6: Patient-reported treatment adherence

Figure 7: Confirmation of the therapeutic effect4

Figure 7: Confirmation of the therapeutic effect
  1. Strollo Jr, Patrick J., et al. Upper-airway stimulation for obstructive sleep apnea. New England Journal of Medicine 370.2 (2014): 139-149.
  2. Woodson, B. Tucker, et al. Randomized controlled withdrawal study of upper airway stimulation on OSA: short-and long-term effect. Otolaryngology–Head and Neck Surgery 151.5 (2014): 880-887.
  3. Woodson, B. Tucker, et al. Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngology–Head and Neck Surgery 154.1 (2016): 181-188.
  4. Woodson, B. Tucker, et al. "Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes." Otolaryngology–Head and Neck Surgery (2018): 0194599818762383.

Adherence data: STAR study data