Inspire therapy is a clinically proven sleep apnea treatment option
The STAR Clinical Trial, involving 126 Obstructive Sleep Apnea (OSA) patients across the United States and Europe, began in 2010 to evaluate the safety and efficacy of Inspire therapy. One-year STAR Trial results were published in the New England Journal of Medicine1, in January 2014, and Inspire therapy received approval by the United States Food and Drug Administration (FDA) in April of that year.
One-year STAR Trial outcomes showed that sleep apnea patients receiving Inspire therapy experienced significant reductions in sleep apnea events and significant improvements in both quality of life and daytime functioning as measured by various questionnaires. There also was a high safety profile, with an overall rate of serious adverse events of <2%.
Recently, three-year study outcomes were published, showing the improvements observed at one-year were sustained at the three-year follow-up mark. Some notable outcomes include:
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Clinical Trial Results
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*As measured by the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire.
â€ Inspire Medical Systems clinical database.
References: 1. 12 Month Data: Strollo et al. NEJM 2014; 2. 36 Month Data: Woodson et al. OTO-HNS 2015