Atlanta, Georgia 30342

  • Obstructive Sleep Apnea

Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure - Age >/= 20 and >/= 65 - Body Mass Index ,/= 32 (kg/m2) - Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP - Signed informed consent to participate in this study Exclusion Criteria: - Prior OSA surgery - Active systemic infection - Allergy to any medication used during implantation - Previous history of neck or upper respiratory tract - Significant dysphagia or speech disorder Anatomical - Identified obvious palatal stenosis - Enlarged tonsils (3+) - Anatomy unable to accommodate the implant Other - Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment - Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study - Unable and/or not willing to comply with treatment follow-up requirements - Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment


NCT ID:

NCT01611779


Primary Contact:

Study Director
Andrew Goldberg, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30342
United States

Samuel Mickelson, MD
Phone: 404-943-0900

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 28, 2021

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