Obstructive Sleep Apnea Clinical Trial
Official title:
Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).
Obstructive sleep apnea (OSA) has become a major health problem in the United States. With
prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been
implicated in increased risk for cardiovascular disease, including hypertension and heart
failure.
The first and most common treatment for OSA is continuous positive airway pressure (CPAP)
treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing
apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP
during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have
shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients
exhibit long-term compliance with CPAP.
It is widely accepted that the region behind the tongue is a major site of collapse during
obstructive sleep apnea. In fact there are many surgical procedures performed currently to
address tongue based collapse. These include RF ablation of the tongue base, genioglossus
advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension.
The current study is designed to evaluate the feasibility of tongue stabilization, and
assess safety and treatment of the tongue stabilization.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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