FAST as a Treatment for Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Encore Tongue Suspension System


Participation Criteria
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Eligibility Criteria
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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/m^2) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongue suspension<br>Tongue-based suspension | Device: Encore Tongue Suspension System<br>* The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.<br>* Other names: FG0002;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Place the Implant and Stabilize the Tongue | Ability to place the implant and stabilize the tongue | Up to 7 weeks after the procedure | 
| Number of Participants Experiencing Complications | Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index | 0 to >30/hour (high value represents worse outcome) | Baseline, 3, and 12 months | 
| Functional Outcomes and Sleep Questionnaire (FOSQ) | Questionnaire: 0 to 120 (high value represents better outcome) | Baseline, 1, 3, 12 months | 
| Snoring Scale (VAS) | 0 to 10 (high value represents worse outcome) | Baseline, 1 week; 1 month, 3 months, 12 months | 
| Epworth Sleeping Scale (ESS) | 0 to 24 (high value represents worse outcome) | Baseline, 1, 3, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, tongue suspension