FAST as a Treatment for Obstructive Sleep Apnea

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Anatomical

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

Arm && Interventions

Group	Intervention	Description
Tongue suspension	Encore Tongue Suspension System	Tongue-based suspension

Primary Outcome Measures

Name	Time	Method
Place the Implant and Stabilize the Tongue	Up to 7 weeks after the procedure	Ability to place the implant and stabilize the tongue
Number of Participants Experiencing Complications	3 months	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.

Secondary Outcome Measures

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