Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Place the Implant and Stabilize the Tongue
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Identified obvious palatal stenosis
- •Enlarged tonsils (3+)
- •Anatomy unable to accommodate the implant
- •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
结局指标
主要结局
Place the Implant and Stabilize the Tongue
时间窗: Up to 7 weeks after the procedure
Ability to place the implant and stabilize the tongue
Number of Participants Experiencing Complications
时间窗: 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.
次要结局
- Functional Outcomes and Sleep Questionnaire (FOSQ)(Baseline, 1, 3, 12 months)
- Snoring Scale (VAS)(Baseline, 1 week; 1 month, 3 months, 12 months)
- Apnea Hypopnea Index(Baseline, 3, and 12 months)
- Epworth Sleeping Scale (ESS)(Baseline, 1, 3, 12 months)